HEALTH-PLUS, SANITEX, RELIANCE, PRE-POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (137 MCG OR LESS)— 510(k) K991969
Substantially EquivalentPamitex Industries Sdn Bhd
FDA 510(k) clearance K991969 for HEALTH-PLUS, SANITEX, RELIANCE, PRE-POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (137 MCG OR LESS), Substantially Equivalent on 1999-09-09. Applicant: Pamitex Industries Sdn Bhd. Device class: 1.
Clearance details
- Applicant
- Pamitex Industries 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
- Seremban, N.S., MY
Recent devices under product code LYY
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More clearances from Pamitex Industries Sdn Bhd
view all- K003350 — HEALTH-PLUS, SANITEX, RELIANCE MULTIPLY POWDER FREE POLYMER AND NITRILE COATED (BLUE)
- K000952 — HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED LATEX EXAMINATION GLOVES - BLUE COLOR
- K001674 — POWDER-FREE LATEX EXAMINATION GLOVES-BLUE COLOR
- K001672 — POWDER-FREE POLYMER-COATED LATEX EXAMINATION GLOVES
- K993756 — HEALTH-PLUS, SANITEX, RELIANCE STERILE POWDER-FREE NITRILE SURGICAL GLOVES
Data sourced from openFDA. This site is unofficial and independent of the FDA.