NUGARD POWDERFREE, BLUE POLYMER COATED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LE— 510(k) K003545
Substantially EquivalentTerang Nusa Sdn Bhd
FDA 510(k) clearance K003545 for NUGARD POWDERFREE, BLUE POLYMER COATED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LE, Substantially Equivalent on 2000-12-21. Applicant: Terang Nusa Sdn Bhd. Device class: 1.
Clearance details
- Applicant
- Terang Nusa 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
- Kota Bharu, MY
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- K151392 — Sensiflex Plus Sterile Latex Green Surgical Glove Powder Free with Protein Content Labeling Claim with 50ug/dm2 or less
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Data sourced from openFDA. This site is unofficial and independent of the FDA.