MAXITEX DUPLEX POWDER FREE LATEX STERILE SURGEON GLOVES PROTEIN LABELING CLAIM (50 MICRGRAMS OR LESS)— 510(k) K010438
Substantially EquivalentTerang Nusa Sdn Bhd
FDA 510(k) clearance K010438 for MAXITEX DUPLEX POWDER FREE LATEX STERILE SURGEON GLOVES PROTEIN LABELING CLAIM (50 MICRGRAMS OR LESS), Substantially Equivalent on 2001-05-01. Applicant: Terang Nusa Sdn Bhd. Device class: 1.
Clearance details
- Applicant
- Terang Nusa Sdn Bhd
- Product code
- Code KGO
- Device class
- Class 1
- Regulation
- 21 CFR 878.4460
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Kota Bharu, MY
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Data sourced from openFDA. This site is unofficial and independent of the FDA.