POLYURETHANE POWDER FREE DENTAL EXAMINATION GLOVE, POLYURETHANE POWDER FREE MEDICAL EXAMINATION GLOVE— 510(k) K991615

Clearance details

Applicant

Maxxim Medical

Product code

Product code LZA

Device class

Class 1

Regulation

21 CFR 880.6250

Advisory panel

General Hospital

Date received

1999-05-10

Decision date

1999-07-30

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Oldsmar, FL, US

• K253508 — Powder Free Nitrite Examination Glove, Cobalt Blue. Violet Blue and White. Non-Sterile2026-10-29
• K262208 — Non-sterile, Powder Free Nitrile Examination Aloe Vera Green Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid +2 more2026-10-01
• K261793 — Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and Black Color)2026-09-09
• K262542 — Biodegradable Nitrile Powder Free Examination Glove, Green +1 more2026-09-09
• K260312 — Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim +1 more2026-09-08

• K023236 — SENSICARE -C SYNTHETIC POLYISOPRENE POWDER-FREE SURGICAL GLOVES2002-11-12
• K021452 — STERILE SENSICARE ADVANTIX POWDER FREE POLYURETHANE MEDICAL/DENTAL EXAMINATION GLOVE2002-08-01
• K011905 — SNIPER ELITE MODEL-OR-E3872XX SERIES2001-08-28
• K002847 — INTRODUCER WITH DISTAL RADIOPAQUE MARKER BAND, MODEL OR-4926XX2001-05-31
• K010297 — SENSICARE SYNTHETIC POWDER FREE SURGICAL GLOVES (POLY ISOPRENE)2001-02-16

Other

1

Total

1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →