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

Shen Wei USA, Inc. — Predicate Candidate Screening

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

114 daysmedian FDA review time

243 days90th percentile

58clearances measured

K-number	Device	Applicant	Decided	Review days
K213141	Biodegradable Powder Free Nitrile Examination Glove, Blue an	Shen Wei USA, Inc.	2022-05-28	243
K213142	Biodegradable Powder Free Flock-Lined Nitrile Examination Gl	Shen Wei USA, Inc.	2022-01-28	123
K213144	Biodegradable Powder Free Vinyl Examination Gloves Blue, Gre	Shen Wei USA, Inc.	2021-12-22	86
K211620	Biodegradable Powder Free Latex Examination Gloves Natural,	Shen Wei USA, Inc.	2021-08-19	85
K211455	Powder Free Nitrile Examination Gloves with Aloe Vera, Orang	Shen Wei USA, Inc.	2021-07-28	79
K202085	Biodegradable Powder Free Neoprene Examination Glove, Low De	Shen Wei USA, Inc.	2021-06-21	329
K202083	Biodegradable Powder Free Nitrile Examination Glove, Blue-Wh	Shen Wei USA, Inc.	2021-03-25	241
K202080	Biodegradable Powder Free Nitroprene Examination Glove, Low	Shen Wei USA, Inc.	2021-03-24	240
K202081	Biodegradable DriTek Powder Free Nitrile Examination Glove,	Shen Wei USA, Inc.	2021-03-19	235
K202082	Biodegradable Powder Free Nitrile Examination Glove, Green-W	Shen Wei USA, Inc.	2021-03-17	233
K202086	Biodegradable Powder Free Nitrile Examination Glove, Low Der	Shen Wei USA, Inc.	2021-03-16	232
K202076	Biodegradable Powder Free Flock-Lined Nitrile Examination Gl	Shen Wei USA, Inc.	2021-03-05	221
K202078	Biodegradable Thermoplastic Elastomer Examination (TPE) Glov	Shen Wei USA, Inc.	2021-03-05	221
K190466	PF Nitrile Exam Glove with pH coating, Black-Gray & White-Bl	Shen Wei USA, Inc.	2019-09-26	212
K173766	PF Nitrile Exam Glove with pH coating, Black-Gray Color, Tes	Shen Wei USA, Inc.	2018-07-08	209
K172678	THERMOPLASTIC ELASTOMER EXAMINATION (TPE) GLOVE	Shen Wei USA, Inc.	2017-11-24	80
K162312	Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera	Shen Wei USA, Inc.	2017-07-25	341
K170290	Powder Free Nitrile Exam Glove w/pH coating, White-Black col	Shen Wei USA, Inc.	2017-05-24	114
K161074	Powder Free Nitrile Examination Gloves Flock-Lined, Black Co	Shen Wei (Usa), Inc.	2016-11-17	213
K121811	POWDER FREE STERILE LATEX EXAM RADIATION ATTENUATION GLOVES	Shen Wei (Usa), Inc.	2012-11-21	154
K121528	POWER-FREE NITRILE EXAMINATION GLOVES, PEPPERMINT SCENTED, B	Shen Wei (Usa), Inc.	2012-09-11	111
K120890	POWDER-FREE NITRIE EXAMINATION GLOVES, ORANGE	Shen Wei (Usa), Inc.	2012-08-17	147
K113233	POWDERED LATEX SURGICAL GLOVES STERILE, STERILE WITH PROTEIN	Shen Wei (Usa), Inc.	2012-03-29	148
K101436	PEARLESCENT POWDER FREE NITRILE EXAMINATION GLOVE WITH ALOE	Shen Wei (Usa), Inc.	2010-11-17	177
K100211	PEARLSCENT BLACK TEXTURED POWDER-FREE LATEX EXAMINATION GLOV	Shen Wei (Usa), Inc.	2010-05-11	106
K092411	PEARLESCENT POWDER FREE NITRILE EXAMINATION GLOVES WITH ALOE	Shen Wei (Usa), Inc.	2009-10-21	75
K090194	POWDER- FREE NITRILE EXAMINATION GLOVES, BLACK COLOR	Shen Wei (Usa), Inc.	2009-07-07	161
K061756	TEXTURED POWDER FREE NITRILE EXAM GLOVES WITH SAP	Shen Wei (Usa), Inc.	2007-04-19	302
K062919	TEXTURED POWDER FREE NITRILE EXAM GLOVES (PEACH)	Shen Wei (Usa), Inc.	2007-03-20	173
K062067	TEXTURED POWER FREE BP2000 (BUTADIENE POLYMER) EXAM GLOVES,	Shen Wei (Usa), Inc.	2006-09-06	47
K060073	TEXTURED POWDER FREE NITRILE EXAM GLOVES (BLACK COLOR), CHEM	Shen Wei (Usa), Inc.	2006-05-01	112
K051683	POWDER-FREE SYNTHETIC VINYL EXAM GLOVES WITH VITAMIN E COATI	Shen Wei (Usa), Inc.	2005-08-01	39
K050467	POWDER FREE BUTADIENE EXAM GLOVES WITH ALOE, GREEN	Shen Wei (Usa), Inc.	2005-03-30	35
K033693	POWDER-FREE VINYL EXAMINATION GLOVES	Shen Wei (Usa), Inc.	2004-01-16	53
K033692	POWDERED VINYL EXAMINATION GLOVES	Shen Wei (Usa), Inc.	2004-01-16	53
K033539	DISPOSAL POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES, GRE	Shen Wei (Usa), Inc.	2004-01-08	59
K030583	POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING C	Shen Wei (Usa), Inc.	2003-11-10	259
K032084	POWDER-FREE SYNTHETIC VINYL EXAMINATION GLOVES, BLUE COLOR	Shen Wei (Usa), Inc.	2003-10-29	114
K032024	POWDER-FREE NITRILE EXAMINATION GLOVES, BLUE COLOR (TESTED F	Shen Wei (Usa), Inc.	2003-10-29	121
K022220	POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING C	Shen Wei (Usa), Inc.	2002-09-23	76
K013794	POWDER-FREE LATEX EXAMINATION GLOVES WITH ALOE AND PROTEIN C	Shen Wei (Usa), Inc.	2002-01-22	69
K013795	POWDER-FREE LATEX EXAMINATION GLOVES WITH ALOE AND PROTEIN C	Shen Wei (Usa), Inc.	2002-01-22	69
K013793	POWDER FREE LATEX EXAMINATION GLOVES WITH ALOE VERA @PH 5.5	Shen Wei (Usa), Inc.	2002-01-22	69
K011961	POWDER-FREE BUTADIENE COPOLYMER EXAM GLOVES WITH ALOE, VITAM	Shen Wei (Usa), Inc.	2001-09-26	96
K011045	TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES CONTAINS 50 MI	Shen Wei (Usa), Inc.	2001-09-11	159
K011044	TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES WITH CONTAINS	Shen Wei (Usa), Inc.	2001-09-10	158
K010110	POWDER-FREE NITRILE EXAMINATION GLOVES, WHITE	Shen Wei (Usa), Inc.	2001-04-03	81
K010097	POWDER-FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA, GREEN	Shen Wei (Usa), Inc.	2001-03-30	78
K991422	POWDER-FREE NITRILE EXAMINATION GLOVE (TESTED FOR USE WITH C	Shen Wei (Usa), Inc.	2000-05-03	376
K993876	POWDER-FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA	Shen Wei (Usa), Inc.	2000-02-07	84

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