Atlas FDA

LATEX PATIENT EXAMINATION GLOVES

FDA 510(k) clearance K895642 · decided 1989-12-05

Clearance details

K-number
K895642
Device name
LATEX PATIENT EXAMINATION GLOVES
Applicant
Siam Sempermed Corp., Ltd.
Decision
Substantially Equivalent
Date received
1989-09-19
Decision date
1989-12-05
Days to decision
77 days
Clearance type
Traditional
Product code
OPE
Advisory committee
General Hospital
Location
Thailand, TH
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Siam Sempermed Corp.

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
B-CARE POWDERED LATEX EXAMINATION GLOVES (K052845)B-Care Industries Co., Ltd.2005-12-16
LATEX EXAMINATION GLOVES (K944778)Pt. Haloni Jane1994-11-17

Recalls involving this device

No recalls on record reference this clearance.