Data / Medical devices / India / Ansell Sterile Solutions Pvt. Ltd
Ansell Sterile Solutions Pvt. Ltd: FDA-registered device maker in Erode Tamil Nadu, India, 4 510(k) clearances
Ansell Sterile Solutions Pvt. Ltd is registered with the FDA (registration 3024706752) in Erode Tamil Nadu, India. It lists 4 device types. The FDA files 4 510(k) clearances under its listings, the newest dated August 3, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3024706752
- Address
- Plot No-KK 10, KK-11, SIPCOT Industrial Park, Phase-II, 3rd Cross Road, Perundurai, Erode Tamil Nadu, India, 638052
- Owner or operator
- ANSELL HEALTHCARE PRODUCTS LLC (8020065)
- Roles
- Contract manufacturer, Contract sterilizer, Manufacturer
- First device listed
- November 21, 2007
- Registered through
- 2026
- Brand names listed
- PI Hybrid Micro
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory, Surgical Apparel | LYU | 1 | Contract manufacturer, Contract sterilizer | accessdata.fda.gov |
| Medical Glove, Specialty | LZC | 1 | Contract manufacturer, Contract sterilizer, Manufacturer | accessdata.fda.gov |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | 1 | Contract manufacturer, Contract sterilizer | accessdata.fda.gov |
| Surgeon'S Gloves | KGO | 1 | Contract manufacturer, Contract sterilizer, 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 |
|---|---|---|---|---|---|---|
| August 3, 2021 | K210724 | ENCORE Latex Acclaim, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (50 ug/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs, GAMMEX Latex Standard, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (50 ug/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs | KGO | Substantially Equivalent | Careplus (M) Sdn Bhd | accessdata.fda.gov |
| June 24, 2021 | K210656 | ENCORE Latex Ortho, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (<50µg/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs, GAMMEX Latex Ortho, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (<50 µg/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs | KGO | Substantially Equivalent | Careplus (M) Sdn Bhd | accessdata.fda.gov |
| May 27, 2021 | K202765 | ENCORE Latex Textured Surgical Gloves, Powder Free with Protein Content Labeling Claim (50 micrograms or less) and Tested for use with Chemotherapy drugs | KGO | Substantially Equivalent | Careplus (M) Sdn Bhd | accessdata.fda.gov |
| February 16, 2000 | K000295 | ENCORE MICROPTIC POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) | KGO | Substantially Equivalent | Ansell Perry | accessdata.fda.gov |
Compare with other makers
- All makers of Surgeon'S Gloves
- All makers of Medical Glove, Specialty
- All makers of Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
- All makers of Accessory, Surgical Apparel
Updated August 3, 2021. 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.