HIGH RISK POWDERFREE LATEX EXAMINATION GLOVES (BLUE COLOUR)— 510(k) K973801
Substantially EquivalentSri Johani Sdn. Bhd.
FDA 510(k) clearance K973801 for HIGH RISK POWDERFREE LATEX EXAMINATION GLOVES (BLUE COLOUR), Substantially Equivalent on 1997-11-21. 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
view all- K250069 — Powder Free Natural Rubber Latex Examination Gloves Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein
- K240266 — Latex Examination Glove Powder Free (Ocean Blue and Natural White)
- 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)
- K993457 — POWDERFREE LATEX EXAMINATION GLOVES (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)
Data sourced from openFDA. This site is unofficial and independent of the FDA.