NUGARD, SENSIFLEX PROCEDURE EXAMINATION GLOVES— 510(k) K083337
Substantially EquivalentTerang Nusa Sdn Bhd
FDA 510(k) clearance K083337 for NUGARD, SENSIFLEX PROCEDURE EXAMINATION GLOVES, Substantially Equivalent on 2009-01-27. 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
- Special
- Location
- Kota Bharu, Kelantan, MY
Recent devices under product code LYY
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- K230573 — Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeling Claim (Contains 50 ug per dm2 of glove or less of Total Water Extractable Protein)
- K223298 — Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L)
- K222612 — Powder-Free Latex examination gloves
More clearances from Terang Nusa Sdn Bhd
view all- K170779 — Nugard Black Powder Free Latex Examination Glove, Polymer Coated, Contains 50 Micrograms or less of water extractable protein
- K161932 — Powder Free Polychloroprene Examination Glove Blue, Powder Free Polychloroprene Examination Glove Pink
- 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.