POWDERED LATEX PATIENT EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMSPER OR LESS)— 510(k) K003737
Substantially EquivalentPerusahaan Getah Asas Sdn. Bhd.
FDA 510(k) clearance K003737 for POWDERED LATEX PATIENT EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMSPER OR LESS), Substantially Equivalent on 2001-02-01. Applicant: Perusahaan Getah Asas Sdn. Bhd.. Device class: 1.
Clearance details
- Applicant
- Perusahaan Getah Asas 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
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Data sourced from openFDA. This site is unofficial and independent of the FDA.