Pristeen (Latex Surgeons Gloves Powder Free, Polymer coated with protein content labeling claim of 50 ug/dm2 or less per glove of extractable protein— 510(k) K172942
Substantially EquivalentBeta Healthcare Products Pvt., Ltd.
FDA 510(k) clearance K172942 for Pristeen (Latex Surgeons Gloves Powder Free, Polymer coated with protein content labeling claim of 50 ug/dm2 or less per glove of extractable protein, Substantially Equivalent on 2018-01-08. Applicant: Beta Healthcare Products Pvt., Ltd.. Device class: 1.
Clearance details
- Applicant
- Beta Healthcare Products Pvt., Ltd.
- Product code
- Code KGO
- Device class
- Class 1
- Regulation
- 21 CFR 878.4460
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Kochi, IN
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Data sourced from openFDA. This site is unofficial and independent of the FDA.