COMFORT LATEX POWDERED PATIENT EXAMINATION GLOVES WITH PROTEIN LABEL CLAIM CONTAINS 200 MICROGRAMS OR LESS OF TOTAL WATE— 510(k) K001042
Substantially EquivalentComfort Rubber Gloves Industries Sdn. Bhd.
FDA 510(k) clearance K001042 for COMFORT LATEX POWDERED PATIENT EXAMINATION GLOVES WITH PROTEIN LABEL CLAIM CONTAINS 200 MICROGRAMS OR LESS OF TOTAL WATE, Substantially Equivalent on 2000-05-23. Applicant: Comfort Rubber Gloves Industries Sdn. Bhd.. Device class: 1.
Clearance details
- Applicant
- Comfort Rubber Gloves 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
- Matang, MY
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Data sourced from openFDA. This site is unofficial and independent of the FDA.