SAFETY POWDERFREE BLUE LATEX EXAMINATION GLOVES (POLYMER COATED)— 510(k) K980941
Substantially EquivalentBesglove Medicare Sdn. Bhd.
FDA 510(k) clearance K980941 for SAFETY POWDERFREE BLUE LATEX EXAMINATION GLOVES (POLYMER COATED), Substantially Equivalent on 1998-04-03. Applicant: Besglove Medicare Sdn. Bhd.. Device class: 1.
Clearance details
- Applicant
- Besglove Medicare 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 Darul Ehsan, 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 Besglove Medicare Sdn. Bhd.
view all- K994082 — POWDERED LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) (50 MICROGRAM OR LESS)
- K993500 — POWDERFREE LATEX EXAMINATION GLOVES (POLYMER COATED) (PROTEIN LABEL OF 50 MCROGRAM OR LESS)
- K993495 — POWDERED LATEX EXAMINATION GLOVES(PROTEIN LABEL CLAIM 150 MICROGRAMS OR LESS)
- K993502 — POWDERFREE LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM 50 MICROGRAMS OR LESS)
- K981877 — NITRILE POWDERFREE EXAMINATION GLOVES
Data sourced from openFDA. This site is unofficial and independent of the FDA.