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560 FDA 510(k) clearances · Product code

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RecordFirmDate
YA MEI FIRST AID KIT (K031130)Ya Mei Technology Co., Ltd.2003-06-27
POWDER FREE LATEX MICROSURGERY GLOVES WITH BROWN COLOR AND PROTEIN LABELING CLAIM OF 50 MICROGRAMS OR LESS PROTEIN GRAM (K030445)Primus Gloves Private , Ltd.2003-06-05
PRE-POWDERED LATEX ORTHOPEDIC SURGEON'S GLOVES (K030444)Primus Gloves Private , Ltd.2003-06-05
POWDER-FREE RADIATION ATTENUATING NEOPRENE SURGICAL GLOVE (BLACK) (K022873)International Biomedical, Inc.2003-03-21
POWDERFREE POLYCHLOROPRENE STERILIZED SURGICAL GLOVES (K030228)Pt. Medisafe Technologies2003-03-14
POWDER FREE LATEX SURGEON'S GLOVES CONTAINS 50 MEGM OR LESS OF TOTAL WATER EXTRACTABLE PER GRAM (K023912)Sanrea Healthcare Private Limited2003-02-11
PRE-POWDERED LATEX SURGEON'S GLOVES (K023515)Sanrea Healthcare Private Limited2003-01-16
POWDER FREE POLYMER COATED GREEN NEOPRENE SURGICAL GLOVES, STERILE (K024130)Wrp Asia Pacific Sdn. Bhd.2002-12-30
SENSICARE -C SYNTHETIC POLYISOPRENE POWDER-FREE SURGICAL GLOVES (K023236)Maxxim Medical2002-11-12
POWDER FREE GREEN NEOPRENE SURGICAL GLOVES, STERILE WITH ALOE VERA (K022444)Wrp Asia Pacific Sdn. Bhd.2002-09-17
POWDER FREE GREEN LATEX SURGICAL GLOVES, STERILE WITH ALOE VERA AND PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM LESS) (K022442)Wrp Asia Pacific Sdn. Bhd.2002-09-05
PROFEEL POWDER FREE POLYMER COATED BROWN LATEX SURGICAL GLOVES, STERILE (PROTEIN LABELING CLAIM) (K021784)Wrp Asia Pacific Sdn. Bhd.2002-07-24
POWDERED BROWN LATEX SURGICAL GLOVES, STERILE WITH EXPIRATION DATE LABELING CLAIM & PROTEIN CONTENT LABELING CLAIM (K021119)Wrp Asia Pacific Sdn. Bhd.2002-07-05
POWDERED LATEX SURGIACAL GLOVES, STEERILE WITH EXPIRATION DATE LABELING CLAIM (K021159)Wrp Asia Pacific Sdn. Bhd.2002-07-03
ELASTYLITE SYNTHETIC POWDERED SURGICAL GLOVE (K021598)Eci Medical Technologies, Inc.2002-06-10
LATEX SURGEONS GLOVE (POWDER FREE) (K014283)Brightway Gloves Pvt. , Ltd.2002-05-22
LATEX SURGEONS GLOVE (POWDERED) (K014278)Brightway Gloves Pvt. , Ltd.2002-05-14
PRE-POWDERED STERILE SURGEON'S GLOVES (WITH A 50 MICROGRAM/GM PROTEIN CLAIM (K021065)Primus Gloves Private , Ltd.2002-05-08
ELASTYFREE SYNTHETIC POWDER-FREE SURGICAL GLOVE (K020918)Eci Medical Technologies, Inc.2002-04-19
REGENT BIOGEL SKINSENSE STERILE POWDER-FREE, SYNTHETIC POLYISOPRENE SURGEON'S GLOVE (K020308)Ssl America'S, Inc.2002-04-03
STERILE POWDER FREE LATEX SURGEON GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS) (K014230)Supermax Glove Manufacturing Sdn Bhd2002-03-13
DERMGRIP POWDER FREE POLYMER COATED LATEX SURGEON'S GLOVES,STERILE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM ORS (K014288)Wrp Specialty Products Sdn. Bhd.2002-02-13
POWDERFREE LATEX SURGEON'S GLOVES (K013914)Kanam Latex Industries Pvt. , Ltd.2002-02-06
POWDER FREE POLYMER COATED LATEX SURGICAL GLOVES, STERILE (PROTEIN LABELING CLAIM) (K020019)Wrp Asia Pacific Sdn. Bhd.2002-01-23
SEMPERMED SUPREME, SIZES 5.5, 6, 6.5, 7, 7.5, 8, 8.5, AND 9 (K013560)Semperit Technische Produkte Gesellshaft2002-01-16
DURAPRENE STERILE SYNTHETIC POWDER-FREE SURGICAL GLOVES WITH TESTED FOR USE WITH CHEMOTHERAPY DRUGS LABELING CLAIM (K013302)Allegiance Healthcare Corp.2001-12-17
STERILE POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CLAIM LESS THAN 50 UG/G (K013727)Smart Glove Corp. Sdn Bhd2001-12-07
HPI SENSI GRIP STERILE POWDERED LATEX SURGICAL GLOVE,WITH LABELED PROTEIN CONTENT AND MADE FROM ALLOTEX AN ENZYME TREAT (K013324)Tillotson Healthcare Corp.2001-11-29
SEMPERMED DERMA PLUS, SIZES 5.5,6,6.5,7,7.5,8,8.5,9 (K012819)Semperit Technische Produkte Gesellshaft2001-11-16
STERILE POWDER-FREE LATEX SURGICAL GLOVES (50 MICROGRAMS OR LESS) (K012880)Ssn Gloves (M) Sdn Bhd2001-11-16
STERILE POWDERED LATEX SURGICAL GLOVES WITH PROTEIN LABELING CLAIM (200 MICROGRAMS OR LESS) (K012896)Ssn Gloves (M) Sdn Bhd2001-11-16
MODIFICATION TO:MICRO TOUCH (R) POWDER FREE LATEX SURGICAL GLOVES , MODEL STYLE 65 (K013603)Ansell Healthcare Products, Inc.2001-11-13
MODIFICATION TO: ULTRALON (R) POWDER FREE LATEX SURGICAL GLOVES (K013604)Ansell Healthcare Products, Inc.2001-11-13
STERILE NITRILE SURGICAL GLOVES (POWDERED) (K012479)Smart Glove Corp. Sdn Bhd2001-09-26
CLINCARE LATEX SURGEON'S GLOVE (K012067)Ttk Healthcare , Ltd.2001-09-17
STERILE LATEX SURGICAL GLOVES (POWDERED) WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS) (K011066)Smart Glove Corp. Sdn Bhd2001-09-11
SNOW LOTUS POWDER-FREE LATEX SURGEON'S GLOVES (K012104)Beijing Reagent Latex Products Co., Ltd.2001-08-21
ESTEEM STERILE POLYISOPRENE SURGICAL GLOVES (K011721)Allegiance Healthcare Corp.2001-08-14
POWDER FREE BROWN LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (K012135)Wrp Asia Pacific Sdn. Bhd.2001-08-01
BARRIERPLUS POWDER-FREE SYNTHETIC POLYISOPRENE SURGICAL GLOVES (K011446)Barriermed, Inc.2001-06-14
ULTRAFREE MAX STERILE LATEX POWEDER-FREE SURGICAL GLOVES WITH PROTEIN LABELING CLAIM, 50 PER GRAM OR LESS OF TOTAL WATER (K010862)Allegiance Healthcare Corp.2001-06-07
MAXITEX DUPLEX POWDER FREE LATEX STERILE SURGEON GLOVES PROTEIN LABELING CLAIM (50 MICRGRAMS OR LESS) (K010438)Terang Nusa Sdn Bhd2001-05-01
MAXITEX DUPLEX STERILE LATEX POWDERED SURGEON GLOVES WITH PROTEIN LABELING CLAIM (100 MICROGRAMS OR LESS) (K010439)Terang Nusa Sdn Bhd2001-05-01
STERILE POWDERED LATEX SURGEON GLOVES (K010198)Supermax Glove Manufacturing Sdn Bhd2001-02-23
X-TENDA CUFF POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM 50 MICROGRAMS OR LESS, MODEL STYLE 21 (K003895)Ansell Perry2001-01-17
ENCORE POWDER-FREE LATEX SURGICAL GLOVES, ORTHOPAEDIC WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (K003771)Ansell Healthcare Products, Inc.2001-01-16
ENCORE MICROPTIC POWDER FREE LATEX SURGICAL GLOVES, MODEL 87 (K003769)Ansell Healthcare Products, Inc.2000-12-22
POWDER FREE STERILE LATEX SURGICAL GLOVES, CONTAINS 50 MICROGRAM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM (K002593)Hartalega Sdn Bhd2000-11-29
GIMBEL PUNCTURE RESISTANT LATEX SURGICAL GLOVE WITH PUNCTURE RESISTANCE FINGERTIP PROTECTION (K003063)Gimbel Glove Co., LLC2000-11-22
PROFEEL POWDER FREE POLYMER COATED NEOPRENE SURGICAL GLOVES STERILE (K003019)Wrp Asia Pacific Sdn. Bhd.2000-11-03
STERILE SENSICARE SYNTHETIC POLYISOPRENE POWDER-FREE SURGICAL GLOVES (K002933)Maxxim Medical2000-10-19
BIOGEL NEOTECH II POWDER-FREE NEOPRENE SURGEON'S GLOVE (K000421)Ssl Americas, Inc. (Regent Medical)2000-08-14
DERMAGUARD PF BROWN POWDER FREE LATEX SURGICAL GLOVES; MODEL STYLE 38 (K002192)Ansell Perry2000-07-27
POWDERED STERILE LATEX SURGICAL GLOVE, WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) (K001959)Hartalega Sdn Bhd2000-07-26
COATED STERILE LATEX POWDEER-FREE SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM OR LESS0 (K001924)Allegiance Healthcare Corp.2000-07-14
LATEX SURGEON SURGEON'S GLOVES POWDER-FREE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (K001274)Pt. Maja Agung Latexindo2000-06-23
EUDERMIC PF POWDER-FREE SURGICAL GLOVES (K001343)Maxxim Medical, Inc.2000-06-12
NUZONE NITRILE SURGICAL GLOVES, POWDERED, GREEN (K000178)Terang Nusa Sdn Bhd2000-05-23
GUTHRIE POWDER-FREE LATEX SURGICAL GLOVE WITH (50 MICROGRAMS OR LESS) (K001049)Guthrie Medicare Products (Melaka) Sdn Bhd2000-05-23
ENCORE POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (K001239)Ansell Perry2000-05-15
NUZONE NITRILE SURGICAL GLOVES POWDER FREE (K000179)Terang Nusa Sdn Bhd2000-05-15
POWDERFREE LATEX SURGEON'S GLOVES WITH PROTIEN LABELING CLAIM (50 MOCROGRAMS OR LESS (K000896)Fitco Dipped Products Pvt., Ltd.2000-05-03
HEALTH-PLUS, SANITEX, RELIANCE STERILE POWDER-FREE NITRILE SURGICAL GLOVES (K993756)Pamitex Industries Sdn Bhd2000-04-28
GUTHRIE LATEX SURGICAL GLOVE (PRE-POWDERED) (K001047)Guthrie Medicare Products (Melaka) Sdn Bhd2000-04-28
PROFEEL POWDER FREE NITRILE SURGICAL GLOVE, STERILE (K000971)Wrp Asia Pacific Sdn. Bhd.2000-04-14
HEALTH-PLUS, SANITEX, RELIANCE POWEDER-FREE STERILE LATEX SURGICAL GLOVES (K993201)Pamitex Industries Sdn Bhd2000-03-29
ENCORE MICROPTIC POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (K000295)Ansell Perry2000-02-16
THE ORIGINAL PERRY, STYLE 42 WHITE LATEX POWDERED SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (60 MICROGRAMS OR (K993857)Ansell Perry2000-01-31
SAFESKIN TACTYLON PF POWDER-FREE SURGEON'S GLOVES (K994081)Safeskin Corp.2000-01-18
LATEX SURGICAL GLOVES, PRE-POWDERED (K993450)Fitco Dipped Products Pvt., Ltd.1999-12-29
POWDER FREE LATEX STERILE SURGICAL GLOVES (K993562)Tg Medical Sdn. Bhd.1999-12-29
DERMAGRIP POWDER-FREE LATEX SURGICAL GLOVE, STERILE (PROTEIN CONTENT LABELING 50 MICROGRAMS OR LESS) (K993214)Wrp Specialty Products Sdn. Bhd.1999-12-02
DERMAGRIP POWDERED LATEX SURGICAL GLOVE, STERILE (K993215)Wrp Specialty Products Sdn. Bhd.1999-12-02
NIL, SURGEON'S GLOVE - POWDER FREE (K993349)Sri Anusham Rubber Industries Pvt., Ltd.1999-11-23
SURGEON'S GLOVES PRE-POWDERED, MODELS 6.5, 7, 7.5, 8, 8.5 (K992752)Pt. Maja Agung Latexindo1999-11-05
SURGEONS GLOVE, BROWN LATEX POLYMER COATED, POWDER FREE WITH PROTEIN LABEL CLAIM (K992953)Ansell Perry1999-10-29
SURGEON POWDER-FREE GLOVES, LATEX, STERILE (K992679)Wear Safe Malaysia Sdn. Bhd.1999-10-21
ULTRADERM STERILE LATEX POWDERED SURGICAL SLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (K991205)Allegiance Healthcare Corp.1999-10-13
COATED STERILE LATEX POWDER-FREE SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (K992171)Allegiance Healthcare Corp.1999-09-14
LAGLOVE BRAND NITRILE SURGICAL GLOVE-STERILE (POWDER-FREE) (K991950)La Glove (M) Sdn. Bhd.1999-08-12
LAGLOVE BRAND NITRILE SURGICAL GLOVE-STERILE (POWDERED) (K991949)La Glove (M) Sdn. Bhd.1999-08-12
LAGLOVE POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (K992019)La Glove (M) Sdn. Bhd.1999-08-05
POWDERED LATEX STERILE SURGICAL GLOVES (K992219)Tg Medical Sdn. Bhd.1999-07-30
LAGLOVE POWDERED LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (150 MICROGRAMS OR LESS) (K992018)La Glove (M) Sdn. Bhd.1999-07-30
BRIGHTWAY BRAND LATEX SURGICAL GLOVES - STERILE (POWDERED) (K992020)Brightsway Holdings Sdn Bhd1999-07-26
BRIGHTWAY BRAND LATEX SURGICAL GLOVES - STERILE (POWDER FREE) (K992021)Brightsway Holdings Sdn Bhd1999-07-23
ULTRAFREE THICK STERILE LATEX POWDER-FREE SURGICAL GLOVES (K991992)Allegiance Healthcare Corp.1999-07-13
NITRILON CORRECT-TOUCH (K984512)Ct Intl.1999-07-12
BRIGHTWAY BRAND NITRILE SURGICAL GLOVES - STERILE (POWDERED) (K991940)Brightway Holdings Sdn. Bhd.1999-07-12
BRIGHTWAY BRAND NITRILE SURGICAL GLOVES - STERILE (POWDER-FREE) (K991939)Brightway Holdings Sdn. Bhd.1999-07-01
POWDER-FREE LATEX SURGEON'S GLOVE SAFESKIN PFS PLUS CONTAINS 50MLGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM (K991317)Safeskin Corp.1999-05-21
SURGEON'S GLOVES (K984395)Sri Anusham Rubber Industries Pvt., Ltd.1999-05-21
BARRIERPLUS SYNTHETIC POWDER-FREE SURGICAL GLOVES (K990710)Barriermed Glove Co.1999-05-20
SENSICARE SYNTHETIC POWDER FREE SURGICAL GLOVES (K983982)Maxxim Medical1999-05-04
ELASTYLON POWDER-FREE SURGICAL GLOVE (K984337)Eci Medical Technologies, Inc.1999-04-09
PROFEEL SYNTHETIC COPOLYMER SURGICAL GLOVES (POWDERED) (K982600)Wembley Rubber Products (M) Sdn Bhd1999-03-12
STERILE POWDER FREE NITRILE SURGEONS GLOVES (NATURAL, BLUE AND GREEN) (K981947)Boston Medical Corp.1999-03-03
DERMA PRENE POWDER-FREE SYNTHETIC SURGICAL GLOVES (CHEMOTHERAPY USE) (K984558)Ansell Perry1999-02-26
ELITE POWDER-FREE POLYURETHANE SYNTHETIC SURGICAL GLOVES (CHEMOTHERAPY USE) (K984559)Ansell Perry1999-02-26
SENSIFLEX POWDERFREE SURGEON'S GLOVE (K982957)Terang Nusa Sdn Bhd1999-01-13
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