Company ยท US
Shen Wei (Usa), Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1989 to 2022. Name variants (Inc, Corp, punctuation) are merged.
58510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 28, 2022 | K213141 | Biodegradable Powder Free Nitrile Examination Glove, Blue and Green colors, Low Dermatitis Potential, Tested for use wit Shen Wei USA, Inc. | LZA |
| Jan 28, 2022 | K213142 | Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and Gray Colors, Tested for use with Chemotherapy Shen Wei USA, Inc. | LZA |
| Dec 22, 2021 | K213144 | Biodegradable Powder Free Vinyl Examination Gloves Blue, Green and White Colors Shen Wei USA, Inc. | LYZ |
| Aug 19, 2021 | K211620 | Biodegradable Powder Free Latex Examination Gloves Natural, Blue, Black and Green Colors with protein content labeling c Shen Wei USA, Inc. | LYY |
| Jul 28, 2021 | K211455 | Powder Free Nitrile Examination Gloves with Aloe Vera, Orange and Orange-White Colors Shen Wei USA, Inc. | LZA |
| Jun 21, 2021 | K202085 | Biodegradable Powder Free Neoprene Examination Glove, Low Dermatitis Potential Claim, Green Shen Wei USA, Inc. | LZA |
| Mar 25, 2021 | K202083 | Biodegradable Powder Free Nitrile Examination Glove, Blue-White Color with Low Dermatitis Potential Claim and Tested for Shen Wei USA, Inc. | LZA |
| Mar 24, 2021 | K202080 | Biodegradable Powder Free Nitroprene Examination Glove, Low Dermatitis Potential Claim, Teal-Black Color Shen Wei USA, Inc. | LZA |
| Mar 19, 2021 | K202081 | Biodegradable DriTek Powder Free Nitrile Examination Glove, Low Dermatitis Potential Claim, Blue Shen Wei USA, Inc. | LZA |
| Mar 17, 2021 | K202082 | Biodegradable Powder Free Nitrile Examination Glove, Green-White and Orange-White Colors with Low Dermatitis Potential C Shen Wei USA, Inc. | LZA |
| Mar 16, 2021 | K202086 | Biodegradable Powder Free Nitrile Examination Glove, Low Dermatitis,Potential Claim, Blue, Green, Black, White, Orange, Shen Wei USA, Inc. | LZA |
| Mar 5, 2021 | K202078 | Biodegradable Thermoplastic Elastomer Examination (TPE) Glove Shen Wei USA, Inc. | LZA |
| Mar 5, 2021 | K202076 | Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and Gray Colors Shen Wei USA, Inc. | LZA |
| Sep 26, 2019 | K190466 | PF Nitrile Exam Glove with pH coating, Black-Gray & White-Black Colors, Tested for Use with chemotheraphy drugs and Fent Shen Wei USA, Inc. | LZA |
| Jul 8, 2018 | K173766 | PF Nitrile Exam Glove with pH coating, Black-Gray Color, Tested for Use with Chemo Drugs Shen Wei USA, Inc. | LZC |
| Nov 24, 2017 | K172678 | THERMOPLASTIC ELASTOMER EXAMINATION (TPE) GLOVE Shen Wei USA, Inc. | LZA |
| Jul 25, 2017 | K162312 | Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color Shen Wei USA, Inc. | LZA |
| May 24, 2017 | K170290 | Powder Free Nitrile Exam Glove w/pH coating, White-Black color, Tested for Use with Chemo dr Shen Wei USA, Inc. | LZA |
| Nov 17, 2016 | K161074 | Powder Free Nitrile Examination Gloves Flock-Lined, Black Color Shen Wei (Usa), Inc. | LZA |
| Nov 21, 2012 | K121811 | POWDER FREE STERILE LATEX EXAM RADIATION ATTENUATION GLOVES Shen Wei (Usa), Inc. | LZC |
| Sep 11, 2012 | K121528 | POWER-FREE NITRILE EXAMINATION GLOVES, PEPPERMINT SCENTED, BLUE COLOR Shen Wei (Usa), Inc. | LZA |
| Aug 17, 2012 | K120890 | POWDER-FREE NITRIE EXAMINATION GLOVES, ORANGE Shen Wei (Usa), Inc. | LZA |
| Mar 29, 2012 | K113233 | POWDERED LATEX SURGICAL GLOVES STERILE, STERILE WITH PROTEIN CONTENT LABELING CLAIM Shen Wei (Usa), Inc. | KGO |
| Nov 17, 2010 | K101436 | PEARLESCENT POWDER FREE NITRILE EXAMINATION GLOVE WITH ALOE VERA (YELLOW, RED, GREEN, BLACK, BLUE) Shen Wei (Usa), Inc. | LZC |
| May 11, 2010 | K100211 | PEARLSCENT BLACK TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES, COATED WITH ALOE VERA Shen Wei (Usa), Inc. | LYY |
| Oct 21, 2009 | K092411 | PEARLESCENT POWDER FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA (YELLOW, RED, GREEN, BLACK, BLUE) Shen Wei (Usa), Inc. | LZA |
| Jul 7, 2009 | K090194 | POWDER- FREE NITRILE EXAMINATION GLOVES, BLACK COLOR Shen Wei (Usa), Inc. | LZA |
| Apr 19, 2007 | K061756 | TEXTURED POWDER FREE NITRILE EXAM GLOVES WITH SAP Shen Wei (Usa), Inc. | LZA |
| Mar 20, 2007 | K062919 | TEXTURED POWDER FREE NITRILE EXAM GLOVES (PEACH) Shen Wei (Usa), Inc. | LZA |
| Sep 6, 2006 | K062067 | TEXTURED POWER FREE BP2000 (BUTADIENE POLYMER) EXAM GLOVES, NATURAL COLOR Shen Wei (Usa), Inc. | LZA |
| May 1, 2006 | K060073 | TEXTURED POWDER FREE NITRILE EXAM GLOVES (BLACK COLOR), CHEMO LABELING Shen Wei (Usa), Inc. | LZA |
| Aug 1, 2005 | K051683 | POWDER-FREE SYNTHETIC VINYL EXAM GLOVES WITH VITAMIN E COATING Shen Wei (Usa), Inc. | LYZ |
| Mar 30, 2005 | K050467 | POWDER FREE BUTADIENE EXAM GLOVES WITH ALOE, GREEN Shen Wei (Usa), Inc. | LZA |
| Jan 16, 2004 | K033693 | POWDER-FREE VINYL EXAMINATION GLOVES Shen Wei (Usa), Inc. | LYZ |
| Jan 16, 2004 | K033692 | POWDERED VINYL EXAMINATION GLOVES Shen Wei (Usa), Inc. | LYZ |
| Jan 8, 2004 | K033539 | DISPOSAL POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES, GREEN COLOR Shen Wei (Usa), Inc. | LYZ |
| Nov 10, 2003 | K030583 | POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINES 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACE Shen Wei (Usa), Inc. | LYY |
| Oct 29, 2003 | K032084 | POWDER-FREE SYNTHETIC VINYL EXAMINATION GLOVES, BLUE COLOR Shen Wei (Usa), Inc. | LYZ |
| Oct 29, 2003 | K032024 | POWDER-FREE NITRILE EXAMINATION GLOVES, BLUE COLOR (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) Shen Wei (Usa), Inc. | LZA |
| Sep 23, 2002 | K022220 | POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIMS, GREEN COLOR Shen Wei (Usa), Inc. | LYY |
| Jan 22, 2002 | K013795 | POWDER-FREE LATEX EXAMINATION GLOVES WITH ALOE AND PROTEIN CLAIM, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, GREEN COLOR Shen Wei (Usa), Inc. | LYY |
| Jan 22, 2002 | K013794 | POWDER-FREE LATEX EXAMINATION GLOVES WITH ALOE AND PROTEIN CLAIM, TESTED FOR USE WITH CHEMOTHERAPY DRUGS Shen Wei (Usa), Inc. | LYY |
| Jan 22, 2002 | K013793 | POWDER FREE LATEX EXAMINATION GLOVES WITH ALOE VERA @PH 5.5 AND PROTEIN LABELING CLAIMS Shen Wei (Usa), Inc. | LYY |
| Sep 26, 2001 | K011961 | POWDER-FREE BUTADIENE COPOLYMER EXAM GLOVES WITH ALOE, VITAMINS E PH5.5 Shen Wei (Usa), Inc. | LZA |
| Sep 11, 2001 | K011045 | TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM Shen Wei (Usa), Inc. | LYY |
| Sep 10, 2001 | K011044 | TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES WITH CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER Shen Wei (Usa), Inc. | LYY |
| Apr 3, 2001 | K010110 | POWDER-FREE NITRILE EXAMINATION GLOVES, WHITE Shen Wei (Usa), Inc. | LZA |
| Mar 30, 2001 | K010097 | POWDER-FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA, GREEN (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) Shen Wei (Usa), Inc. | LZA |
| May 3, 2000 | K991422 | POWDER-FREE NITRILE EXAMINATION GLOVE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) Shen Wei (Usa), Inc. | LZA |
| Feb 7, 2000 | K993876 | POWDER-FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA Shen Wei (Usa), Inc. | LZA |
Newest 50 of 58.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||