POWDERFREE LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) [50 MICROGRAMS OR LESS]— 510(k) K993457
Substantially EquivalentSri Johani Sdn. Bhd.
FDA 510(k) clearance K993457 for POWDERFREE LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) [50 MICROGRAMS OR LESS], Substantially Equivalent on 1999-12-02. Applicant: Sri Johani Sdn. Bhd.. Device class: 1.
Clearance details
- Applicant
- Sri Johani 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
- Selangor, 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 Sri Johani Sdn. Bhd.
view all- K993454 — POWDERFREE LATEX EXAMINATION GLOVES (POLYMER COATED) (PROTEIN LABEL CLAIM - 50 MICROGRAMS OR LESS)
- K993458 — POWDERED LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM)
- K981039 — POWDERFREE GREEN NITRILE EXAMINATION GLOVES (POLYMER COATED)
- K980037 — POWDERFREE GREEN LATEX EXAMINATION GLOVES (POLYMER COATED)
- K980038 — POWDERFREE GREEN LATEX EXAMINATION GLOVES
Data sourced from openFDA. This site is unofficial and independent of the FDA.