Powder Free Natural Rubber Latex Examination Gloves Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein— 510(k) K250069
Substantially EquivalentComfort Rubber Gloves Industries Sdn. Bhd.
FDA 510(k) clearance K250069 for Powder Free Natural Rubber Latex Examination Gloves Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein, Substantially Equivalent on 2025-04-29. 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
Recent devices under product code LYY
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- K222612 — Powder-Free Latex examination gloves
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More clearances from Comfort Rubber Gloves Industries Sdn. Bhd.
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- K192954 — Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl
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Data sourced from openFDA. This site is unofficial and independent of the FDA.