OPE

FDA Product Code OPE:

Leading manufacturers include B-Care Industries Co., Ltd., Siam Sempermed Corp., Ltd. and Pt. Haloni Jane.

3
Total
3
Cleared
66d
Avg days
1989
Since

FDA 510(k) Cleared OPE Devices (Product Code OPE)

3 devices
1–3 of 3
Cleared Dec 16, 2005
B-CARE POWDERED LATEX EXAMINATION GLOVES
K052845
B-Care Industries Co., Ltd.
General & Plastic Surgery · 70d
Cleared Nov 17, 1994
LATEX EXAMINATION GLOVES
K944778
Pt. Haloni Jane
General & Plastic Surgery · 51d
Cleared Dec 05, 1989
LATEX PATIENT EXAMINATION GLOVES
K895642
Siam Sempermed Corp., Ltd.
General & Plastic Surgery · 77d

About Product Code OPE - Regulatory Context