Powder-Free Polyisoprene Sterile Surgical Gloves in White Color Tested for Use with Chemotherapy Drugs, Powder-Free Polyisoprene Sterile Surgical Gloves in Green Color.— 510(k) K142941

Clearance details

Applicant

Pt. Medisafe Technologies

Product code

Code KGO

Device class

Class 1

Regulation

21 CFR 878.4460

Advisory panel

General, Plastic Surgery

Date received

2014-10-09

Decision date

2015-11-02

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Tanjung Morawa, Medan, ID

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• Z-1725-2026 — Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: GLOVE PACK 7.0 (15PK), Medline SKU # DYNJ63673DClass I·Ongoing·Medline Industries, LP·20260227

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K142941.