PATIENT LATEX EXAMINATION GLOVE (PREPOWDERED)— 510(k) K971629
Substantially EquivalentBesglove Medicare Sdn. Bhd.
FDA 510(k) clearance K971629 for PATIENT LATEX EXAMINATION GLOVE (PREPOWDERED), Substantially Equivalent on 1997-08-06. 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
- Kajang,Selangor Darul,Ehasan, 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.