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510(k) K211667

Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile) by Changzhou Universal Medical Equipment Co., Ltd. — Product Code LAZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 2021
Date Received
June 1, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
N-Acetylprocainamide Control Materials
Device Class
Class I
Regulation Number
862.3280
Review Panel
TX
Submission Type

Other clearances by Changzhou Universal Medical Equipment Co., Ltd.

  • K213910 — Disposable Medical Nitrile Examination Gloves- Tested for Use with Chemotherapy (March 10, 2022)
  • K210145 — Nitrile Glove Powder Free Blue (April 21, 2021)

Other clearances for product code LAZ

  • K851474 — VYGON SPINAL ANESTHESIA TRAY CODE NO. 190 (May 7, 1985)
  • K823127 — ADVANCE EMIT-CAD PROCAINAMIDE/N-ACETYL (November 29, 1982)
  • K811461 — EMIT-AND METHOTREXATE CONTROL (June 9, 1981)