UNISEAL GLOVES LOW PROTEIN POWDERED— 510(k) K981979
Substantially EquivalentAmerican Healthcare Products (M) Sdn Bhd
FDA 510(k) clearance K981979 for UNISEAL GLOVES LOW PROTEIN POWDERED, Substantially Equivalent on 1998-11-30. Applicant: American Healthcare Products (M) Sdn Bhd. Device class: 1.
Clearance details
- Applicant
- American Healthcare Products (M) 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
- Nilai, Negeri Sembilan 71800, MY
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More clearances from American Healthcare Products (M) Sdn Bhd
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