Shen Wei (USA), Inc.
Union City, CA, US
Shen Wei (Usa), Inc. appears in FDA device records in Union City, CA. FDA records list 58 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 58
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 58FDA records hold 58 510(k) clearances for Shen Wei (USA), Inc. between 1989 and 2022. The busiest year on record is 2021, with 11. The most recent is 2022, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1989 | 1 |
| 1994 | 1 |
| 1996 | 2 |
| 1997 | 2 |
| 1999 | 2 |
| 2000 | 2 |
| 2001 | 5 |
| 2002 | 4 |
| 2003 | 3 |
| 2004 | 3 |
| 2005 | 2 |
| 2006 | 2 |
| 2007 | 2 |
| 2009 | 2 |
| 2010 | 2 |
| 2012 | 4 |
| 2016 | 1 |
| 2017 | 3 |
| 2018 | 1 |
| 2019 | 1 |
| 2021 | 11 |
| 2022 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K213141 | Biodegradable Powder Free Nitrile Examination Glove, Blue and Green colors, Low Dermatitis Potential, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate-Simulated Gastric Acid Solution | LZA | Substantially Equivalent | |
| K213142 | Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and Gray Colors, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate Simulated Gastric Acid Solution | LZA | Substantially Equivalent | |
| K213144 | Biodegradable Powder Free Vinyl Examination Gloves Blue, Green and White Colors | LYZ | Substantially Equivalent | |
| K211620 | Biodegradable Powder Free Latex Examination Gloves Natural, Blue, Black and Green Colors with protein content labeling claim (50 micrograms or less) | LYY | Substantially Equivalent | |
| K211455 | Powder Free Nitrile Examination Gloves with Aloe Vera, Orange and Orange-White Colors | LZA | Substantially Equivalent | |
| K202085 | Biodegradable Powder Free Neoprene Examination Glove, Low Dermatitis Potential Claim, Green | LZA | Substantially Equivalent | |
| K202083 | Biodegradable Powder Free Nitrile Examination Glove, Blue-White Color with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs | LZA | Substantially Equivalent | |
| K202080 | Biodegradable Powder Free Nitroprene Examination Glove, Low Dermatitis Potential Claim, Teal-Black Color | LZA | Substantially Equivalent | |
| K202081 | Biodegradable DriTek Powder Free Nitrile Examination Glove, Low Dermatitis Potential Claim, Blue | LZA | Substantially Equivalent | |
| K202082 | Biodegradable Powder Free Nitrile Examination Glove, Green-White and Orange-White Colors with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid | LZA | Substantially Equivalent | |
| K202086 | Biodegradable Powder Free Nitrile Examination Glove, Low Dermatitis,Potential Claim, Blue, Green, Black, White, Orange, Black-White, Teal-Gray, White-Green, White-Orange, White-Blue, Blue-White, Green-White, Orange-White Colors | LZA | Substantially Equivalent | |
| K202078 | Biodegradable Thermoplastic Elastomer Examination (TPE) Glove | LZA | Substantially Equivalent | |
| K202076 | Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and Gray Colors | LZA | Substantially Equivalent | |
| K190466 | PF Nitrile Exam Glove with pH coating, Black-Gray & White-Black Colors, Tested for Use with chemotheraphy drugs and Fentanyl Citrate | LZA | Substantially Equivalent | |
| K173766 | PF Nitrile Exam Glove with pH coating, Black-Gray Color, Tested for Use with Chemo Drugs | LZC | Substantially Equivalent | |
| K172678 | THERMOPLASTIC ELASTOMER EXAMINATION (TPE) GLOVE | LZA | Substantially Equivalent | |
| K162312 | Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color | LZA | Substantially Equivalent | |
| K170290 | Powder Free Nitrile Exam Glove w/pH coating, White-Black color, Tested for Use with Chemo dr | LZA | Substantially Equivalent | |
| K161074 | Powder Free Nitrile Examination Gloves Flock-Lined, Black Color | LZA | Substantially Equivalent | |
| K121811 | POWDER FREE STERILE LATEX EXAM RADIATION ATTENUATION GLOVES | LZC | Substantially Equivalent | |
| K121528 | POWER-FREE NITRILE EXAMINATION GLOVES, PEPPERMINT SCENTED, BLUE COLOR | LZA | Substantially Equivalent | |
| K120890 | POWDER-FREE NITRIE EXAMINATION GLOVES, ORANGE | LZA | Substantially Equivalent | |
| K113233 | POWDERED LATEX SURGICAL GLOVES STERILE, STERILE WITH PROTEIN CONTENT LABELING CLAIM | KGO | Substantially Equivalent | |
| K101436 | PEARLESCENT POWDER FREE NITRILE EXAMINATION GLOVE WITH ALOE VERA (YELLOW, RED, GREEN, BLACK, BLUE) | LZC | Substantially Equivalent | |
| K100211 | PEARLSCENT BLACK TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES, COATED WITH ALOE VERA | LYY | Substantially Equivalent | |
| K092411 | PEARLESCENT POWDER FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA (YELLOW, RED, GREEN, BLACK, BLUE) | LZA | Substantially Equivalent | |
| K090194 | POWDER- FREE NITRILE EXAMINATION GLOVES, BLACK COLOR | LZA | Substantially Equivalent | |
| K061756 | TEXTURED POWDER FREE NITRILE EXAM GLOVES WITH SAP | LZA | Substantially Equivalent | |
| K062919 | TEXTURED POWDER FREE NITRILE EXAM GLOVES (PEACH) | LZA | Substantially Equivalent | |
| K062067 | TEXTURED POWER FREE BP2000 (BUTADIENE POLYMER) EXAM GLOVES, NATURAL COLOR | LZA | Substantially Equivalent | |
| K060073 | TEXTURED POWDER FREE NITRILE EXAM GLOVES (BLACK COLOR), CHEMO LABELING | LZA | Substantially Equivalent | |
| K051683 | POWDER-FREE SYNTHETIC VINYL EXAM GLOVES WITH VITAMIN E COATING | LYZ | Substantially Equivalent | |
| K050467 | POWDER FREE BUTADIENE EXAM GLOVES WITH ALOE, GREEN | LZA | Substantially Equivalent | |
| K033693 | POWDER-FREE VINYL EXAMINATION GLOVES | LYZ | Substantially Equivalent | |
| K033692 | POWDERED VINYL EXAMINATION GLOVES | LYZ | Substantially Equivalent | |
| K033539 | DISPOSAL POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES, GREEN COLOR | LYZ | Substantially Equivalent | |
| K030583 | POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINES 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACE | LYY | Substantially Equivalent | |
| K032084 | POWDER-FREE SYNTHETIC VINYL EXAMINATION GLOVES, BLUE COLOR | LYZ | Substantially Equivalent | |
| K032024 | POWDER-FREE NITRILE EXAMINATION GLOVES, BLUE COLOR (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) | LZA | Substantially Equivalent | |
| K022220 | POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIMS, GREEN COLOR | LYY | Substantially Equivalent | |
| K013795 | POWDER-FREE LATEX EXAMINATION GLOVES WITH ALOE AND PROTEIN CLAIM, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, GREEN COLOR | LYY | Substantially Equivalent | |
| K013794 | POWDER-FREE LATEX EXAMINATION GLOVES WITH ALOE AND PROTEIN CLAIM, TESTED FOR USE WITH CHEMOTHERAPY DRUGS | LYY | Substantially Equivalent | |
| K013793 | POWDER FREE LATEX EXAMINATION GLOVES WITH ALOE VERA @PH 5.5 AND PROTEIN LABELING CLAIMS | LYY | Substantially Equivalent | |
| K011961 | POWDER-FREE BUTADIENE COPOLYMER EXAM GLOVES WITH ALOE, VITAMINS E PH5.5 | LZA | Substantially Equivalent | |
| K011045 | TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM | LYY | Substantially Equivalent | |
| K011044 | TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES WITH CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER | LYY | Substantially Equivalent | |
| K010110 | POWDER-FREE NITRILE EXAMINATION GLOVES, WHITE | LZA | Substantially Equivalent | |
| K010097 | POWDER-FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA, GREEN (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) | LZA | Substantially Equivalent | |
| K991422 | POWDER-FREE NITRILE EXAMINATION GLOVE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) | LZA | Substantially Equivalent | |
| K993876 | POWDER-FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA | LZA | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain