SENSTOUCH NITRILE EXAMINATION GLOVES, POWDER FREE, NON STERILE (GREEN, ORANGE, VIOLET AND WHITE)— 510(k) K111300

Clearance details

Applicant

Pt Mahakarya Inti Buana

Product code

Product code LZA

Device class

Class 1

Regulation

21 CFR 880.6250

Advisory panel

General Hospital

Date received

2011-05-09

Decision date

2011-08-12

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Sumatera Utara, ID

• 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

• K090464 — BLACK NITRILE EXAMINATION GLOVES, POWDER FREE, NON STERILE2009-04-23
• K063581 — SENSTOUCH HIGH RISK BLUE LATEX EXAMINATION GLOVES, POWDERED, NON STERILE2007-03-15
• K062313 — SENSTOUCH HIGH RISK LATEX EXAMINATION GLOVES, POWDER FREE, NON STERILE2006-11-30
• K061233 — SENSTOUCH POWDER FREE EXAMINATION GLOVES, NON STERILE2006-11-03
• K053305 — SENSTOUCH POWDERED EXAMINATION GLOVES, NON STERILE2006-06-02

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 →