POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES LABELING CONTENT: 100 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEI— 510(k) K992870
Substantially EquivalentAlliance Rubber Products Sdn. Bhd.
FDA 510(k) clearance K992870 for POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES LABELING CONTENT: 100 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEI, Substantially Equivalent on 1999-10-15. Applicant: Alliance Rubber Products Sdn. Bhd.. Device class: 1.
Clearance details
- Applicant
- Alliance Rubber Products Sdn. Bhd.
- Product code
- Code LYY
- Device class
- Class 1
- Regulation
- 21 CFR 880.6250
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Nibong Tebal, Pulau Pinang, MY
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Data sourced from openFDA. This site is unofficial and independent of the FDA.