SURGEON POWDER-FREE GLOVES, LATEX, STERILE— 510(k) K992679
Substantially EquivalentWear Safe Malaysia Sdn. Bhd.
FDA 510(k) clearance K992679 for SURGEON POWDER-FREE GLOVES, LATEX, STERILE, Substantially Equivalent on 1999-10-21. Applicant: Wear Safe Malaysia Sdn. Bhd.. Device class: 1.
Clearance details
- Applicant
- Wear Safe Malaysia 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
- Port Klang, Selangor, D.E., MY
Recent devices under product code KGO
view all- K260558 — Latex Powder Free Surgical Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate +1 more
- K253060 — Sterile Latex Powder Free Surgical Gloves
- K250313 — Sterile Powder Free Synthetic Rubber Surgeons Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid
- 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 Wear Safe Malaysia Sdn. Bhd.
view all- K172420 — Sterile Powder Free Nitrile Surgical Glove, White Colored. Tested for Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim
- K101799 — POWDER FREE LATEX EXAMINATION GLOVES BLUE (COLORED), NON-STERILE, WITH PROTEIN LABELING CLAIM OF 50UG PER DM2 OF GLOVE
- K093500 — POWDER FREE NITRILE EXAMINATION GLOVES, WHITE (NON-COLORED) OR BLUE (COLORED), NON-STERILE
- K092492 — POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, NON-STERILE, WITH PROTEIN LABELING CLAIM OF 50 MICROGRAMS PER DM2 O
- K090066 — POWDER FREE POLYMER COATED LATEX SURGICAL GLOVES, STERILE, WITH PROTEIN LABELING CLAIM OF 50 MICROGRAMS PER DM2 OF GLOVE
Data sourced from openFDA. This site is unofficial and independent of the FDA.