Latex Surgeons Gloves Powder Free with protein content labeling claim of 50µg/dm2 or less per glove of extractable protein— 510(k) K190632
Substantially EquivalentLenora Glove Pvt , Ltd.
FDA 510(k) clearance K190632 for Latex Surgeons Gloves Powder Free with protein content labeling claim of 50µg/dm2 or less per glove of extractable protein, Substantially Equivalent on 2019-10-24. Applicant: Lenora Glove Pvt , Ltd.. Device class: 1.
Clearance details
- Applicant
- Lenora Glove 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
- Coimbatore, IN
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Data sourced from openFDA. This site is unofficial and independent of the FDA.