POLYMER COATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)— 510(k) K013554
Substantially EquivalentMaxter Glove Manufacturing Sdn Bhd
FDA 510(k) clearance K013554 for POLYMER COATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS), Substantially Equivalent on 2002-01-17. Applicant: Maxter Glove Manufacturing Sdn Bhd. Device class: 1.
Clearance details
- Applicant
- Maxter 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
- Klang Selangor, MY
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More clearances from Maxter Glove Manufacturing Sdn Bhd
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- K151390 — Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs
- K113100 — POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS
- K040176 — MAXTER POWDER FREE NITRILE MEDICAL EXAMINATION GLOVES
- K032501 — MAXTER STERILE POWDER FREE SURGICAL GLOVES
Data sourced from openFDA. This site is unofficial and independent of the FDA.