Data / Medical devices / United States / Atlantic Safety Products, Inc.
Atlantic Safety Products, Inc.: FDA-registered device maker in Pittsfield, NH, United States, 8 510(k) clearances
Atlantic Safety Products, Inc. is registered with the FDA (registration 1221744) in Pittsfield, NH, United States. It lists 2 device types. The FDA files 8 510(k) clearances under its listings, the newest dated January 17, 2013. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1221744
- Address
- 55 Barnstead Rd, Pittsfield, NH, United States, 03263
- Owner or operator
- Atlantic Safety Products, Inc. (10025484)
- Roles
- Repackager or relabeler
- First device listed
- January 27, 2010
- Registered through
- 2027
- Brand names listed
- Latex Patient Examination Glove, Latex patient examination glove, Polymer Patient Examination Glove, Polymer patient examination glove, Powder-Free Nitrile Examination Gloves, Orange
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Latex Patient Examination Glove | LYY | 1 | Repackager or relabeler | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| January 17, 2013 | K122408 | POWDER FREE NITRILE EXAMINATION GLOVES (BLACK, WHITE, GREEN) | LZA | Substantially Equivalent | Hongye Plastic Products Co., Ltd. | accessdata.fda.gov |
| August 17, 2012 | K120890 | POWDER-FREE NITRIE EXAMINATION GLOVES, ORANGE | LZA | Substantially Equivalent | Shen Wei (Usa), Inc. | accessdata.fda.gov |
| April 22, 2011 | K102902 | RUBBERCARE POWDER FREE LATEX EXAMINATION GLOVE, BLUE COLOR | LYY | Substantially Equivalent | Rubbercare Protection Products Sdn Bhd | accessdata.fda.gov |
| July 7, 2009 | K090194 | POWDER- FREE NITRILE EXAMINATION GLOVES, BLACK 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 |
| May 3, 2000 | K991422 | POWDER-FREE NITRILE EXAMINATION GLOVE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) | LZA | Substantially Equivalent | Shen Wei (Usa), Inc. | accessdata.fda.gov |
| January 12, 2000 | K993567 | INNOVATIVE GLOVES LATEX EXAMINATION GLOVES POWDERFREE WITH PROTEIN LABELING CLAIM [50 MICROGRAMS OR LESS] | LYY | Substantially Equivalent | Innovative Gloves Co;, Ltd. | accessdata.fda.gov |
| August 14, 1996 | K962461 | NITRILE POWDER-FREE PATIENT EXAMINATION GLOVES | LZA | Substantially Equivalent | Shen Wei (Usa), Inc. | accessdata.fda.gov |
Compare with other makers
Updated January 17, 2013. 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.