POWDER FREE LATEX SURGEONS GLOVES POLYMER COATED STERILE WITH OPTIONAL LABELING CLAIM OF E.P. LESS THAN 50 UG/DM2— 510(k) K033564
Substantially EquivalentKanam Latex Industries Pvt. , Ltd.
FDA 510(k) clearance K033564 for POWDER FREE LATEX SURGEONS GLOVES POLYMER COATED STERILE WITH OPTIONAL LABELING CLAIM OF E.P. LESS THAN 50 UG/DM2, Substantially Equivalent on 2004-02-24. Applicant: Kanam Latex Industries Pvt. , Ltd.. Device class: 1.
Clearance details
- Applicant
- Kanam Latex Industries 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
- Traditional
- Location
- Kottayam, Kerala, IN
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