BRIGHTWAY BRAND LATEX SURGICAL GLOVES - STERILE (POWDER FREE)— 510(k) K992021
Substantially EquivalentBrightsway Holdings Sdn Bhd
FDA 510(k) clearance K992021 for BRIGHTWAY BRAND LATEX SURGICAL GLOVES - STERILE (POWDER FREE), Substantially Equivalent on 1999-07-23. Applicant: Brightsway Holdings Sdn Bhd. Device class: 1.
Clearance details
- Applicant
- Brightsway Holdings 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
- Traditional
- Location
- Klang, Selangor Darul Ehsan, MY
Recent devices under product code KGO
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- K240790 — Polyisoprene Surgical gloves
- K232079 — Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl (Green) +1 more
More clearances from Brightsway Holdings Sdn Bhd
view all- K992020 — BRIGHTWAY BRAND LATEX SURGICAL GLOVES - STERILE (POWDERED)
- K991750 — BRIGHTWAY BRAND BLUE COLOR LATEX EXAMINATION GLOVE, POWDER FREE CONTAINING 50 MLGM OR LESS OF WATER EXTRACTABLE PROTEIN
- K991752 — BRIGHTWAY BRAND BLUE COLOR LATEX EXAMINATION GLOVE, POWDERED CONTAINING 150 MLGM OR LESS OF WATER EXTRACTABLE PROTEIN PE
Data sourced from openFDA. This site is unofficial and independent of the FDA.