POWDERED LATEX MEDICAL MEDICAL EXAMINATION GLOVES WITH 150 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER DM2— 510(k) K013443
Substantially EquivalentMaxter Glove Manufacturing Sdn Bhd
FDA 510(k) clearance K013443 for POWDERED LATEX MEDICAL MEDICAL EXAMINATION GLOVES WITH 150 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER DM2, Substantially Equivalent on 2001-11-29. 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
- 41050 Klang, Selangor, MY
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Data sourced from openFDA. This site is unofficial and independent of the FDA.