Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Sgmp Co., Ltd. — Predicate Candidate Screening

31 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

35 daysmedian FDA review time

213 days90th percentile

31clearances measured

K-number	Device	Applicant	Decided	Review days
K112693	NON-STERILE, POWER FREE YELLOW LATEX EXAMINATION GLOVES	Sgmp Co., Ltd.	2012-09-12	363
K101822	NON-STERILE POWDER-FREE BLUE NITRILE EXAMINATION GLOVES TEST	Sgmp Co., Ltd.	2010-11-19	142
K101646	NON-STERILE, POWDER FREE BLACK NITRILE EXAMINATION GLOVES WI	Sgmp Co., Ltd.	2010-09-08	89
K072400	NON-STERILE, POWDER-FREE, BLACK NITRILE EXAMINATION GLOVES	Sgmp Co., Ltd.	2008-03-27	213
K072403	NON-STERILE, POWDERED, PINK LATEX EXAMINATION GLOVES WITH CH	Sgmp Co., Ltd.	2008-03-27	213
K072406	NON-STERILE, POWDER FREE, PINK LATEX EXAMINATION GLOVES WITH	Sgmp Co., Ltd.	2008-03-21	207
K071060	NON-STERILE, LATEX POWDER FREE PATIENT EXAMINATION GLOVES (M	Sgmp Co., Ltd.	2007-07-26	101
K052016	NON-STERILE POWDER FREE MULTICOLOR - RED, BLUE, PURPLE AND Y	Sgmp Co., Ltd.	2005-09-01	37
K042879	NON-STERILE POWDER-FREE BLUE NITRILE EXAMINATION GLOVES, WIT	Sgmp Co., Ltd.	2005-01-13	87
K023537	NON-STERILE POWDER FREE GREEN LATEX PATIENT EXAM GLOVES WITH	Sgmp Co., Ltd.	2003-11-20	395
K032293	NON-STERILE, POWDER FREE GREEN LATEX EXAMINATION GLOVES WITH	Sgmp Co., Ltd.	2003-08-28	34
K032294	NON-STERILE, POWDER FREE ORANGE LATEX EXAMINATION GLOVES W/	Sgmp Co., Ltd.	2003-08-28	34
K030993	NON-STERILE POWDERED GREEN COLORED POWDERED LATEX PATIENT EX	Sgmp Co., Ltd.	2003-06-12	76
K030994	NON-STERILE ORANGE COLORED POWDERED LATEX PATINET EXAMINATIO	Sgmp Co., Ltd.	2003-06-12	76
K020317	NON-STERILE POWDER FREE GREEN BARRIER-PRO SYNTHETIC BUTADIEN	Sgmp Co., Ltd.	2002-02-14	15
K013288	NON-STERILE POWDER FREE GREEN LATEX EXAMINATION GLOVES WITH	Sgmp Co., Ltd.	2001-12-03	62
K012863	NON-STERILE POWDER FREE LATEX EXAMINATION GLOVES WITH VANILL	Sgmp Co., Ltd.	2001-09-21	28
K012857	NON-STERILE POWDER FREE PURPLE LATEX EXAMINATION GLOVE WITH	Sgmp Co., Ltd.	2001-09-21	28
K012860	POWDER-FREE LATEX EXAM GLOVES WITH CHOCOLATE SCENTING AND PR	Sgmp Co., Ltd.	2001-09-21	28
K011377	NON-STERILE POWDER-FREE BLUE LATEX EXAMINATION GLOVES, WITH	Sgmp Co., Ltd.	2001-06-07	34
K011370	NON-STERILE POWDER FREE PURPLE LATEX EXAMINATION GLOVE WITH	Sgmp Co., Ltd.	2001-06-07	34
K011371	NON-STERILE POWDER FREE PINK LATEX EXAMINATION GLOVE AND NON	Sgmp Co., Ltd.	2001-06-07	34
K010095	NONSTERILE POWDERED PURPLE LATEX EXAMINATION GLOVES, WITH &	Sgmp Co., Ltd.	2001-02-09	29
K002175	NON-STERILE POWDER FREE BUBBLE-GUM SCENTED LATEX EXAMINATION	Sgmp Co., Ltd.	2000-07-31	12
K002176	NON-STERILE POWDER FREE PINEAPPLE SCENTED LATEX EXAMINATION	Sgmp Co., Ltd.	2000-07-31	12
K000867	POWDER FREE LATEX EXAMINATION GLOVES, PEPPERMINT SCENTED (CO	Sgmp Co., Ltd.	2000-04-21	35
K000868	NON-STERILE POWDER-FREE, BLUE NITRILE EXAMINATION GLOVES	Sgmp Co., Ltd.	2000-04-20	34
K000391	VITAL SHIELD GOLD POWDER FREE LATEX EXAMINATION GLOVES WITH	Sgmp Co., Ltd.	2000-04-12	65
K000390	VITAL SHIELD GOLD POWDERED LATEX EXAMINATION GLOVES WITH PRO	Sgmp Co., Ltd.	2000-04-12	65
K000671	POWDERED LATEX EXAM GLOVES, PINK, WITH/WITHOUT STRAWBERRY SC	Sgmp Co., Ltd.	2000-03-29	30
K000488	VITAL SHIELD GOLD NON-STERILE POWDERED LATEX EXAM GLOVES BLU	Sgmp Co., Ltd.	2000-03-20	35

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda