SUR-G GLOV AND MAXITEX— 510(k) K102119
Substantially EquivalentTerang Nusa Sdn Bhd
FDA 510(k) clearance K102119 for SUR-G GLOV AND MAXITEX, Substantially Equivalent on 2010-08-27. Applicant: Terang Nusa Sdn Bhd. Device class: 1.
Clearance details
- Applicant
- Terang Nusa Sdn Bhd
- Product code
- Code KGO
- Device class
- Class 1
- Regulation
- 21 CFR 878.4460
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Kota Bharu, Kelantan, MY
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More clearances from Terang Nusa Sdn Bhd
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- K153510 — Powder Free Polychloroprene Examination Glove Green
- K151392 — Sensiflex Plus Sterile Latex Green Surgical Glove Powder Free with Protein Content Labeling Claim with 50ug/dm2 or less
- K140355 — SENSIFLEX PLUS STERILE LATEX SURGICAL GLOVE POWDERFREE WITH PROTEIN CONTENT LABELING CLAIM
Data sourced from openFDA. This site is unofficial and independent of the FDA.