COMFIT POWDER FREE BLUE EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN)— 510(k) K962188
Substantially EquivalentWembley Rubber Products (M) Sdn Bhd
FDA 510(k) clearance K962188 for COMFIT POWDER FREE BLUE EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN), Substantially Equivalent on 1996-07-26. Applicant: Wembley Rubber Products (M) Sdn Bhd. Device class: 1.
Clearance details
- Applicant
- Wembley Rubber Products (M) 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
- Salak Tinggi, Sepang Selangor, MY
Recent devices under product code LYY
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- K223298 — Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L)
- K222612 — Powder-Free Latex examination gloves
More clearances from Wembley Rubber Products (M) Sdn Bhd
view all- K982600 — PROFEEL SYNTHETIC COPOLYMER SURGICAL GLOVES (POWDERED)
- K972616 — ONCOLOGY PLUS POWDER FREE LATEX EXAMINATION GLOVES (PROTEIN CONTENT LABELING)
- K972615 — CHEMO PLUS POWDER FREE BLUE LATEX EXAMINATION GLOVES (PROTEIN CONTENT LABELING)
- K972621 — PROFEEL POWDER FREE SURGICAL GLOVES (PROTEIN CONTENT LABELING)
- K953213 — COMFIT (POWDER FREE EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN, BEADED)
Data sourced from openFDA. This site is unofficial and independent of the FDA.