BRIGHTWAY BRAND POLYMER COATED LATEX EXAMINATION GLOVE (POWDER FREE)— 510(k) K990543
Substantially EquivalentBrightway Holdings Sdn. Bhd.
FDA 510(k) clearance K990543 for BRIGHTWAY BRAND POLYMER COATED LATEX EXAMINATION GLOVE (POWDER FREE), Substantially Equivalent on 1999-04-09. Applicant: Brightway Holdings Sdn. Bhd.. Device class: 1.
Clearance details
- Applicant
- Brightway Holdings 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
- Klang, Selangor Darul Ehsan, MY
Recent devices under product code LYY
view all- K250069 — Powder Free Natural Rubber Latex Examination Gloves Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein
- K240266 — Latex Examination Glove Powder Free (Ocean Blue and Natural White)
- 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 Brightway Holdings Sdn. Bhd.
view all- K211816 — Brightway Brand, Nitrile Examination Gloves, Powder Free (Blue) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
- K170686 — Nitrile Examination Gloves, Powder Free [Purple] Tested for Use with Chemotherapy Drugs
- K162294 — BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12, POWDER FREE, [PURPLE] TESTED FOR USE WITH CHEMOTHERAPY DRUGS
- K162186 — BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12, POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM
- K163267 — NITRILE EXAMINATION GLOVE
Data sourced from openFDA. This site is unofficial and independent of the FDA.