KLEARTEX LATEX SURGEONS GLOVES— 510(k) K904361

Name: FDA 510(k) clearance K904361
Creator: U.S. Food and Drug Administration
Published: 1990-12-07

Substantially Equivalent

Kleartex Sdn Bhd

FDA 510(k) clearance K904361 for KLEARTEX LATEX SURGEONS GLOVES, Substantially Equivalent on 1990-12-07. Applicant: Kleartex Sdn Bhd. Device class: 1.

Clearance details

Applicant: Kleartex Sdn Bhd
Product code: Code KGO
Device class: Class 1
Regulation: 21 CFR 878.4460
Advisory panel: General, Plastic Surgery
Date received: 1990-09-24
Decision date: 1990-12-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chester, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KGO

view all

K260558 — Latex Powder Free Surgical Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate +1 more2026-07-28
K253060 — Sterile Latex Powder Free Surgical Gloves2026-05-22
K250313 — Sterile Powder Free Synthetic Rubber Surgeons Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid2025-08-19
K240790 — Polyisoprene Surgical gloves2024-08-23
K232079 — Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl (Green) +1 more2024-03-28

More clearances from Kleartex Sdn Bhd

view all

K890975 — PATIENT EXAMINATION GLOVE1989-05-11

Data sourced from openFDA. This site is unofficial and independent of the FDA.