SUPERGLOVES STERILE POWDERED LATEX EXAMINATION GLOVES— 510(k) K000644
Substantially EquivalentSupermax Glove Manufacturing Sdn Bhd
FDA 510(k) clearance K000644 for SUPERGLOVES STERILE POWDERED LATEX EXAMINATION GLOVES, Substantially Equivalent on 2000-03-17. Applicant: Supermax Glove Manufacturing Sdn Bhd. Device class: 1.
Clearance details
- Applicant
- Supermax Glove Manufacturing 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 Supermax Glove Manufacturing Sdn Bhd
view all- K024083 — GREEN POWDER FREE NITRILE MEDICAL EXAMINATION GLOVES WITH PEPPERMINT FLAVOR
- K014230 — STERILE POWDER FREE LATEX SURGEON GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS)
- K013953 — AURELIA CHLORINATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH ALOE VERA AND GINSENG WITH PROTEIN LABELING CLAIM
- K013589 — CHLORINATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH ALOE VERA
- K010198 — STERILE POWDERED LATEX SURGEON GLOVES
Data sourced from openFDA. This site is unofficial and independent of the FDA.