MULTIPLE— 510(k) K945164
Substantially EquivalentProtection Gloves Sdn. Bhd.
FDA 510(k) clearance K945164 for MULTIPLE, Substantially Equivalent on 1995-02-03. Applicant: Protection Gloves Sdn. Bhd.. Device class: 1.
Clearance details
- Applicant
- Protection Gloves 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
- Johor Bahru, 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 Protection Gloves Sdn. Bhd.
view all- K010854 — CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVES, (BLUE, GREEN)
- K011231 — CHLORINATED POWDERED LATEX EXAMINATION GLOVES, BLUE, GREEN
- K000667 — POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABEL CLAIM CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER LABEL CLAIM
- K000668 — POWDER-FREE NON-VHLORINATED POLYMER COATED LATEX EXAMINATION GLOVES CONTAINS 100 MICROGRAMS OR LESS OF TOTAL WATER EXTRA
Data sourced from openFDA. This site is unofficial and independent of the FDA.