Atlas FDA

Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

LYZ — Predicate Candidate Screening

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

70 daysmedian FDA review time
216 days90th percentile
799clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K260860Powder Free Synthetic Vinyl Exam Gloves (Blue, Black)Basic Medical Technology, Inc.2026-04-07220
K252467Disposable Vinyl Examination GlovesViet Phu Trade and Import Export Co., Ltd.2025-10-27820
K252505Powder-Free Vinyl Exam Gloves, clearBasic Medical Technology, Inc.2025-08-28200
K241252Disposable Vinyl Examination GlovesAnqing Pukang Medical Technology Co., Ltd.2024-05-20170
K230046Vinyl examination glovesGuangdong Kingfa Sci. & Tech.Co., Ltd.2023-03-25780
K221980Disposable Powder Free Vinyl Examination Gloves, Beige/ClearEver Global (Vietnam) Enterprise Corporation2023-02-062160
K220992Disposable Powder Free Vinyl Exam Glove, Black/Blue/PurpleEver Global (Vietnam) Enterprise Corporation2022-10-191980
K223008Disposable Vinyl Examination GlovesJiangxi Handspro Products Solutions Co., Ltd.2022-10-0890
K222442DISPOSABLE VINYL EXAMINATION GLOVES (Pink, Black, Blue)Anhui Bytech Medical Supplies Co., Ltd.2022-09-28470
K220055Disposable, vinyl examination gloves, YellowDezhou Hengchang Medical Technology Co., Ltd.2022-08-252310
K220469Disposable Vinyl Examination GloveChifeng Huawei Medical Science&Technology Co., Ltd.2022-06-161180
K220240Vinyl Co-Polymer Powder-free Examination Gloves, BlackGrand Work Plastic Products Co., Ltd.2022-03-31620
K213634Vinyl/Nitrile Blend Exam GloveDezhou Hengchang Medical Technology Co., Ltd.2022-02-18930
K213625Vinyl Examination GlovesDezhou Hengchang Medical Technology Co., Ltd.2022-02-17920
K212011Vinyl Powder Free Examination GloveTop Glove Vietnam Company Limited2022-02-142310
K213019Vinyl Exam GlovesHebei Astro Medical Supply Co., Ltd.2022-01-051070
K212436NBR Synthetic Nitrile Examination GlovesShandong Langtai International Trade Co., Ltd.2021-12-231410
K213144Biodegradable Powder Free Vinyl Examination Gloves Blue, GreShen Wei USA, Inc.2021-12-22860
K213006Vinyl Examination GlovesTaian Hengchang Medical Technology Co., Ltd.2021-12-21920
K211865Powder Free Vinyl Patient Examination Gloves, Clear (non-colLiao Ning Shangwei Medical Products Co., Ltd.2021-12-201870
K212899Disposable Vinyl/Nitrile Blend Medical Examination GlovesBytech(Dongtai) Co., Ltd.2021-12-11890
K212488Synthetic Nitrile Examination GlovesShandong Hongxin Chemicals Co., Ltd.2021-11-261090
K211103Powder Free Vinyl Examination GlovesShanghai Shengda Medical Applications Co., Ltd.2021-11-042050
K211698Vinyl Examination Gloves(Yellow)Liuping Trading Co., Ltd.2021-10-241430
K211236Disposable Vinyl Examination GlovesTangshan Hongyun Healthcare Products Co., Ltd.2021-09-271540
K212002Synthetic Vinyl Examination GlovesYunnan Huazhiyuan Medical Technology Co., Ltd.2021-09-23870
K211904Vinyl GloveJiangsu Dihong Industry and Trade Co., Ltd.2021-09-17880
K211516Disposable Vinyl Nitrile Synthetic Gloves Powder FreeTangshan Hongyun Plastic Products Co., Ltd.2021-08-24990
K211354Disposable Synthetic Vinyl Nitrile Examination GloveJiangsu Cureguard Glove Co., Ltd.2021-08-08970
K211229Vinyl compound examination glovesHebei Titans Hongsen Medical Technology Co., Ltd.2021-07-29970
K211262Disposable Vinyl Nitrile Synthetic Gloves Powder FreeTangshan Hongyun Healthcare Products Co., Ltd.2021-07-24890
K211239Vinyl Patient Examination GlovesJiangxi Shengda Medical Technology Co., Ltd.2021-07-17820
K211177Powder Free Vinyl Patient Examination GlovesShijiazhuang Hongjun Plastic Manufacture Co., Ltd.2021-07-17880
K210821Medical PVC Examination GlovesJiangxi Hongda Medical Equipment Group , Ltd.2021-07-091120
K211045Synthetic Vinyl Examination GlovesJiangsu Huayuan Medical Technology Co., Ltd.2021-06-23760
K211336Disposable Vinyl Examination GloveInner Mongolia Cureguard Medical Materials Co., Ltd.2021-06-16440
K210522Disposable Vinyl Examination GlovesShandong Shengshixincheng Medical Science & Technology Co.,2021-06-101070
K210520Disposable Synthetic Examination GlovesShandong Shengshixincheng Medical Science & Technology Co.,2021-05-26920
K210460NitriTec Vinyl Glove Powder Free BlueZhonghong Pulin Medical Products Co., Ltd.2021-05-17900
K210774Powder Free Vinyl Patient Examination Gloves, Clear (non-colShandong Jieshi Medical Products Co., Ltd.2021-05-14600
K210799Powder Free Vinyl Patient Examination GlovesYunnan Huazhiyuan Medical Technology Co., Ltd.2021-05-14590
K210780Powder Free Vinyl Patient Examination Gloves, Clear (non-colShandong Shangwei Medical Products Co., Ltd.2021-05-14600
K201504Single-use medical poly (vinyl chloride) examination gloveAnhui Bytech Medical Supplies Co., Ltd.2021-05-103390
K203666Vinyl Examination Gloves(Yellow)Lutai Medical Technology Co., Ltd.2021-03-12860
K203439Disposable Vinyl Examination GlovesShandong Zhushi Pharmaceutical Group Co., Ltd.2021-02-26950
K203702Vinyl Examination Gloves (Yellow)Xinying Trading Co., Ltd.2021-02-12560
K202179Medline Glide-On 3G Vinyl Examination Gloves (Tested for useMedline Industries, Inc.2020-10-26830
K202010Disposable Vinyl GloveBetter Health Medical Products Co., Ltd.2020-10-16870
K202008Disposable Vinyl GloveBest Care Trading Co., Ltd.2020-09-10510
K192985Medline Glide-On 3G Vinyl Examination GlovesMedline Industries, Inc.2020-01-21880

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