PATIENT LATEX EXAMINATION GLOVE POWDERED & POWDER FREE, STERILE— 510(k) K992681
Substantially EquivalentWear Safe Malaysia Sdn. Bhd.
FDA 510(k) clearance K992681 for PATIENT LATEX EXAMINATION GLOVE POWDERED & POWDER FREE, STERILE, Substantially Equivalent on 1999-12-16. Applicant: Wear Safe Malaysia Sdn. Bhd.. Device class: 1.
Clearance details
- Applicant
- Wear Safe Malaysia 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
- Port Klang, Selangor, D.E., MY
Recent devices under product code LYY
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- K230573 — Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeling Claim (Contains 50 ug per dm2 of glove or less of Total Water Extractable Protein)
- K223298 — Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L)
- K222612 — Powder-Free Latex examination gloves
More clearances from Wear Safe Malaysia Sdn. Bhd.
view all- K172420 — Sterile Powder Free Nitrile Surgical Glove, White Colored. Tested for Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim
- K101799 — POWDER FREE LATEX EXAMINATION GLOVES BLUE (COLORED), NON-STERILE, WITH PROTEIN LABELING CLAIM OF 50UG PER DM2 OF GLOVE
- K093500 — POWDER FREE NITRILE EXAMINATION GLOVES, WHITE (NON-COLORED) OR BLUE (COLORED), NON-STERILE
- K092492 — POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, NON-STERILE, WITH PROTEIN LABELING CLAIM OF 50 MICROGRAMS PER DM2 O
- K090066 — POWDER FREE POLYMER COATED LATEX SURGICAL GLOVES, STERILE, WITH PROTEIN LABELING CLAIM OF 50 MICROGRAMS PER DM2 OF GLOVE
Data sourced from openFDA. This site is unofficial and independent of the FDA.