Data / Medical devices / United States / SW Technologies Inc.
SW Technologies Inc.: FDA-registered device maker in Union City, CA, United States, 30 510(k) clearances
SW Technologies Inc. is registered with the FDA (registration 2939388) in Union City, CA, United States. It lists 8 device types. The FDA files 30 510(k) clearances under its listings, the newest dated June 24, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 2939388
- Address
- 33278 Central Ave., Suite 102, Union City, CA, United States, 94587
- Owner or operator
- SW TECHNOLOGIES INC. (2939388)
- Roles
- Manufacturer, Remanufacturer, Repackager or relabeler, Reprocessor, Specification developer
- First device listed
- July 17, 2006
- Registered through
- 2027
- Brand names listed
- Aloeform Soft Nitrile Exam Gloves, Aloeform X6 Nitrile Exam Gloves, Aloetuff Nitrile Exam Gloves, Atlantic Safety-Black Lightning Nitrile Exam Gloves, BIODEGRADABLE NITRILE EXAM GLOVE WITH ALOE VERA, Biodegradable DriTek Powder Free Nitrile Examination Glove, Biodegradable Powder Free Nitrile Examination Glove,, Biodegradable Powder Free Nitroprene Examination Glove and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Fentanyl And Other Opioid Protection Glove | QDO | 1 | Manufacturer, Remanufacturer, Repackager or relabeler, Reprocessor, Specification developer | accessdata.fda.gov |
| Latex Patient Examination Glove | LYY | 1 | Manufacturer | accessdata.fda.gov |
| Medical Glove, Specialty | LZC | 1 | Manufacturer, Remanufacturer, Repackager or relabeler, Reprocessor, Specification developer | accessdata.fda.gov |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | 1 | Manufacturer, Remanufacturer, Repackager or relabeler, Reprocessor, Specification developer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Manufacturer, Remanufacturer, Repackager or relabeler, Reprocessor, Specification developer | accessdata.fda.gov |
| Shield, Protective, Personnel | KPY | 1 | Manufacturer | accessdata.fda.gov |
| Surgeon'S Gloves | KGO | 1 | Manufacturer | accessdata.fda.gov |
| Vinyl Patient Examination Glove | LYZ | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 24, 2026 | K252117 | Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate-Simulated Gastric Acid Solution | LZA | Substantially Equivalent | Sw Technologies, Inc. | accessdata.fda.gov |
| March 25, 2021 | 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 | Shen Wei USA, Inc. | accessdata.fda.gov |
| March 24, 2021 | K202080 | Biodegradable Powder Free Nitroprene Examination Glove, Low Dermatitis Potential Claim, Teal-Black Color | LZA | Substantially Equivalent | Shen Wei USA, Inc. | accessdata.fda.gov |
| March 19, 2021 | K202081 | Biodegradable DriTek Powder Free Nitrile Examination Glove, Low Dermatitis Potential Claim, Blue | LZA | Substantially Equivalent | Shen Wei USA, Inc. | accessdata.fda.gov |
| March 17, 2021 | 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 | Shen Wei USA, Inc. | accessdata.fda.gov |
| March 16, 2021 | 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 | Shen Wei USA, Inc. | accessdata.fda.gov |
| November 24, 2017 | K172678 | THERMOPLASTIC ELASTOMER EXAMINATION (TPE) GLOVE | LZA | Substantially Equivalent | Shen Wei USA, Inc. | accessdata.fda.gov |
| July 25, 2017 | K162312 | Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color | LZA | Substantially Equivalent | Shen Wei USA, Inc. | accessdata.fda.gov |
| May 24, 2017 | K170290 | Powder Free Nitrile Exam Glove w/pH coating, White-Black color, Tested for Use with Chemo dr | LZA | Substantially Equivalent | Shen Wei USA, Inc. | accessdata.fda.gov |
| November 17, 2016 | K161074 | Powder Free Nitrile Examination Gloves Flock-Lined, Black Color | LZA | Substantially Equivalent | Shen Wei (Usa), Inc. | accessdata.fda.gov |
| January 16, 2015 | K142862 | POWDER FREE NITRILE EXAMINATION GLOVE, BLUE (Colored). | LZA | Substantially Equivalent | Careplus (M) Sdn Bhd | accessdata.fda.gov |
| November 21, 2012 | K121811 | POWDER FREE STERILE LATEX EXAM RADIATION ATTENUATION GLOVES | LZC | Substantially Equivalent | Shen Wei (Usa), Inc. | accessdata.fda.gov |
| September 11, 2012 | K121528 | POWER-FREE NITRILE EXAMINATION GLOVES, PEPPERMINT SCENTED, BLUE COLOR | LZA | Substantially Equivalent | Shen Wei (Usa), Inc. | accessdata.fda.gov |
| March 29, 2012 | K113233 | POWDERED LATEX SURGICAL GLOVES STERILE, STERILE WITH PROTEIN CONTENT LABELING CLAIM | KGO | Substantially Equivalent | Shen Wei (Usa), Inc. | accessdata.fda.gov |
| July 7, 2009 | K090194 | POWDER- FREE NITRILE EXAMINATION GLOVES, BLACK COLOR | LZA | Substantially Equivalent | Shen Wei (Usa), Inc. | accessdata.fda.gov |
| April 19, 2007 | K061756 | TEXTURED POWDER FREE NITRILE EXAM GLOVES WITH SAP | LZA | Substantially Equivalent | Shen Wei (Usa), Inc. | accessdata.fda.gov |
| September 6, 2006 | K062067 | TEXTURED POWER FREE BP2000 (BUTADIENE POLYMER) EXAM GLOVES, NATURAL COLOR | LZA | Substantially Equivalent | Shen Wei (Usa), Inc. | accessdata.fda.gov |
| May 1, 2006 | K060073 | TEXTURED POWDER FREE NITRILE EXAM GLOVES (BLACK COLOR), CHEMO LABELING | LZA | Substantially Equivalent | Shen Wei (Usa), Inc. | accessdata.fda.gov |
| January 8, 2004 | K033539 | DISPOSAL POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES, GREEN COLOR | LYZ | Substantially Equivalent | Shen Wei (Usa), Inc. | accessdata.fda.gov |
| September 23, 2002 | K022220 | POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIMS, GREEN COLOR | LYY | Substantially Equivalent | Shen Wei (Usa), Inc. | accessdata.fda.gov |
| January 22, 2002 | K013795 | POWDER-FREE LATEX EXAMINATION GLOVES WITH ALOE AND PROTEIN CLAIM, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, GREEN COLOR | LYY | Substantially Equivalent | Shen Wei (Usa), Inc. | accessdata.fda.gov |
| January 22, 2002 | K013794 | POWDER-FREE LATEX EXAMINATION GLOVES WITH ALOE AND PROTEIN CLAIM, TESTED FOR USE WITH CHEMOTHERAPY DRUGS | LYY | Substantially Equivalent | Shen Wei (Usa), Inc. | accessdata.fda.gov |
| January 22, 2002 | K013793 | POWDER FREE LATEX EXAMINATION GLOVES WITH ALOE VERA @PH 5.5 AND PROTEIN LABELING CLAIMS | LYY | Substantially Equivalent | Shen Wei (Usa), Inc. | accessdata.fda.gov |
| September 26, 2001 | K011961 | POWDER-FREE BUTADIENE COPOLYMER EXAM GLOVES WITH ALOE, VITAMINS E PH5.5 | LZA | Substantially Equivalent | Shen Wei (Usa), Inc. | accessdata.fda.gov |
| September 11, 2001 | K011045 | TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM | LYY | Substantially Equivalent | Shen Wei (Usa), Inc. | accessdata.fda.gov |
| September 10, 2001 | K011044 | TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES WITH CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER | LYY | Substantially Equivalent | Shen Wei (Usa), Inc. | accessdata.fda.gov |
| March 30, 2001 | K010097 | POWDER-FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA, GREEN (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) | LZA | Substantially Equivalent | Shen Wei (Usa), Inc. | accessdata.fda.gov |
| November 5, 1997 | K972090 | POWDER-FREE HYPOALLERGENIC NITRILE EXAMINATION GLOVES | LZA | Substantially Equivalent | Shen Wei (Usa), Inc. | accessdata.fda.gov |
| February 10, 1997 | K964628 | NITRILE POWDER-FREE EXAMINATION GLOVES | LZA | Substantially Equivalent | Shen Wei (Usa), Inc. | accessdata.fda.gov |
| May 25, 1989 | K892742 | PATIENT EXAMINATION GLOVES (LATEX) | LYY | Substantially Equivalent | Shen Wei (Usa), Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Polymer Patient Examination Glove
- All makers of Vinyl Patient Examination Glove
- All makers of Latex Patient Examination Glove
- All makers of Surgeon'S Gloves
- All makers of Medical Glove, Specialty
- All makers of Shield, Protective, Personnel
Updated June 24, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.