Atlas FDA

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

KGO · Predicate Candidate Screening

560 FDA 510(k) clearances under this product code; the 50 most recent screened below.

98 daysmedian FDA review time
255 days90th percentile
560clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K260558Latex Powder Free Surgical Gloves Tested for Use with ChemotHartalega NGC Sdn. Bhd.2026-07-281590
K253060Sterile Latex Powder Free Surgical GlovesProtect Gloves Company Limited2026-05-222420
K250313Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, GreenHarps Europe Manufacturing GmbH2025-08-191970
K240790Polyisoprene Surgical glovesSuzhou Colour-Way New Material Co., Ltd.2024-08-231540
K232079Natural Rubber Latex Surgical Glove, Powder Free, Sterile, TWrp Asia Pacific Sdn. Bhd.2024-03-282590
K232444Sterile Powder Free Latex Surgical Gloves, Tested for Use wiGrand Work Plastic Products Co., Ltd.2023-12-201280
K231902GAMMEX PI Hybrid Micro (340002055); GAMMEX PI Hybrid Micro (Ansell Healthcare2023-10-201140
K231973PolyIsoprene Powder Free Black Colour Radiation Attenuating Ineo Tech Sdn Bhd2023-09-29880
K231446Single-Use Latex Sterile Surgical Gloves (SG100)Fitone Latex Products Co., Ltd. Guangdong2023-09-221270
K230578Polyisoprene Surgical Glove (Unified Double Layer), Sterile,Wrp Asia Pacific Sdn. Bhd.2023-08-311830
K230079Polyisoprene Surgical Gloves Tested for Use with ChemotherapAnsell Healthcare Products, LLC2023-08-232250
K222993Flexylon Surgical Powder Free Gloves with Low Dermatitis PotSentienx Sdn Bhd2023-08-183240
K230832Powdered Free Sterile Natural Rubber Latex Surgical GlovesThe Egyptian Company For Medical & Electronic Industries2023-08-161420
K230304Polyisoprene Surgical GlovesPuyang Linshi Medical Supplies Co., Ltd.2023-08-091870
K213289Gammex® PI Plus Glove-in-Glove™ System Tested For Use with CAnsell Healthcare Products, LLC2023-05-266020
K230217Sterile Polyisoprene Powder Free Surgical Glove, Tested for Grand Work Plastic Products Co., Ltd.2023-05-131070
K222350Sterile Nitrile Surgical Gloves Powder FreeJr Engineering & Medical Technologies (M) Sdn. Bhd.2023-04-132530
K222620Sterilized Latex Surgical GlovesSuzhou Colour-Way New Material Co., Ltd.2023-03-232050
K221424Sterile Surgical Powder Free Latex GloveNew Era Medicare Sdn. Bhd.2023-01-262550
K222058Polyisoprene Surgical Glove, Powder Free, Sterile, Tested foWrp Asia Pacific Sdn. Bhd.2022-10-221020
K221718Polyisoprene Powder Free Surgical Glove Tested for Use with Hartalega NGC Sdn. Bhd.2022-09-241030
K221748Medispo Rubber Surgical Gloves, Medispo Polyisoprene SurgicaGuilin Hbm Health Protections, Inc.2022-09-13890
K214074Latex Powder Free Surgical Glove with Protein Labeling ClaimHartalega NGC Sdn. Bhd.2022-05-261500
K211953Disposable Sterilized Latex Surgical GlovesJiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd.2022-05-253360
K212596Sterile Latex Surgical Gloves Powder FreeAmazing Rubber Products Pvt, Ltd.2022-03-011970
K212848Sterile Latex Surgical Gloves Powder FreePentavest Holdings Sdn Bhd2021-12-271110
K210969NulifeMrk Healthcare Pvt, Ltd.2021-11-032170
K211621Latex Surgical Gloves, Powder Free with Protein claim (50 miCareplus (M) Sdn Bhd2021-10-061330
K201592Cardinal Health Protexis PI Blue with Neu-Thera Surgical GloCardinal Health200, LLC2021-09-264710
K211478Sterile Latex Surgical Gloves Powder FreeAspen Glove Sdn. Bhd.2021-09-161270
K210724ENCORE Latex Acclaim, Powder Free Latex Surgical Gloves withCareplus (M) Sdn Bhd2021-08-031460
K203538SensiCare PI Ortho LT Surgical Glove (Tested for Use with ChMedline Industries, Inc.2021-08-022420
K200915Powder Free White Sterilized Polyisoprene Surgical Gloves-TeGx Corporation Sdn Bhd2021-07-094590
K210656ENCORE Latex Ortho, Powder Free Latex Surgical Gloves with PCareplus (M) Sdn Bhd2021-06-241120
K203030POWDER FREE NITRILE SURGICAL GLOVE, STERILE, TESTED FOR USE Wrp Asia Pacific Sdn. Bhd.2021-06-112520
K202765ENCORE Latex Textured Surgical Gloves, Powder Free with ProtCareplus (M) Sdn Bhd2021-05-272480
K202401Powder Free NR Latex Surgical Glove (Sterile) with Protein cEco Medi Glove Sdn. Bhd.2021-02-171800
K203483Medispo Rubber Surgical Gloves, Medispo Polyisoprene SurgicaGuilin Hbm Health Protections, Inc.2021-02-01660
K192933Polyisoprene Powder Free, Black Colour Surgical GlovesEmerson & Co. Srl2021-01-134540
K202668Signature Latex and Signature Latex Micro, Powder-Free, SurgMedline Industries, Inc.2020-12-19960
K202090Biogel Eclipse / Biogel Eclipse Indicator Underglove, BiogelMolnlycke Health Care Us, LLC2020-11-221170
K202449Signature Latex LT, Powder-Free, Surgical Glove, Tested for Medline Industries, Inc.2020-11-18840
K201748Latex Powder Free Surgical Glove with Protein Labelling ClaiHartalega Sdn Bhd2020-10-02980
K201774Polychloroprene Powder Free Sterile Surgical Gloves, Low DerPt. Medisafe Technologies2020-09-16790
K201829SensiCare PI Evolution Surgical Glove (Tested for Use with CMedline Industries, Inc.2020-09-09690
K200897Polyisoprene Powder Free Surgical Underglove for Use with ChHartalega Sdn Bhd2020-06-01590
K193573Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch,Molnlycke Health Care Us, LLC2020-04-101090
K193217SensiCare PI and SensiCare PI Micro Surgical GlovesMedline Industries, Inc.2020-04-061370
K192988Dermasure Green Sterile SyntheticPolychloroprene Powder-FreeMedline Industries, Inc.2020-04-011590
K191860Sterile Powder-Free Synthetic Rubber Surgeon’s Glove with LoSemperit Technische Produkte Gesellchaft M.B.H.2020-03-312640

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