Aerostar

No FDA recalls found in the data synced 10 Oct 2026.

510(k) Number

K921313 ↗

FDA Product Code

CBN

Device Class

Class II

Regulation

21 CFR Part 868.5430

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• P2 Nitrile Exam Gloves

  Class I

  FDA 510(k) K944095 Active Cleared 28 Oct 1994

• P2/Chemo Plus Gloves

  Class I

  FDA 510(k) K900368 Active Cleared 8 Mar 1990

• Chemoplus Glove

  Class I

  FDA 510(k) K901411 Active Cleared 7 Jun 1990

• Chemo Gloves Powder Free (Mfg: Union Industrial)

  Class I

  FDA 510(k) K904130 Active Cleared 10 Oct 1990

• Chemoguard, P2 Hirisk

  Class II

  FDA 510(k) K952274 Active Cleared 29 Aug 1995

• P2 Exam Gloves

  Class I

  FDA 510(k) K944142 Active Cleared 28 Oct 1994

See all devices from Biosafety Systems, Inc. →