LATEX PATIENT EXAMINATION GLOVES POWDERED WITH PROTEIN CONTENT LABELING CLAIM; 100 MICROGRAM OR LESS OF TOTAL WATER EXTR— 510(k) K002314
Substantially EquivalentPerusahaan Getah Asas Sdn. Bhd.
FDA 510(k) clearance K002314 for LATEX PATIENT EXAMINATION GLOVES POWDERED WITH PROTEIN CONTENT LABELING CLAIM; 100 MICROGRAM OR LESS OF TOTAL WATER EXTR, Substantially Equivalent on 2000-08-17. 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
Recent devices under product code LYY
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More clearances from Perusahaan Getah Asas Sdn. Bhd.
view all- K102790 — POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED NON-STERILE (LOW DERAMATITIS POTENTIAL AND CHEMOTHERAPY DRUG
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- K032374 — POWDER-FREE NITRILE PATIENT CHEMOTHERAPY EXAMINATION GLOVE, BLUE COLORED
- K031625 — POWDER-FREE BARRIER-PRO CO-POLYMER EXAMINATION GLOVE, WHITE (NON-COLORED), AND GREEN COLORED
- K031768 — BARRIER-PRO CO-POLYMER PATIENT EXAMINATION GLOVE, POWDERED, WHITE (NON-COLORED) OR GREEN COLORED
Data sourced from openFDA. This site is unofficial and independent of the FDA.