510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K915636Substantially Equivalent

Glove Check Patient Examination Glove Leak Detect.

Associated Ent., Inc., Jonesborough TN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K915636 is the FDA 510(k) clearance record for GLOVE CHECK PATIENT EXAMINATION GLOVE LEAK DETECT., cleared for Associated Ent., Inc. on under FDA product code LDQ. FDA records list 4 510(k) clearances for Associated Ent., Inc., from to . As of , FDA records show no recalls naming K915636.

Clearance record

Decision date
Received
(209 days to decision)
Product code
LDQ
Review panel
General Hospital
Applicant
Associated Ent., Inc. 623 Charlie Hicks Rd., Jonesborough TN
510(k) summary
Statement
Third party review
No

Clearances, product code LDQ

Trailing 12 months

FDA records hold no clearances under product code LDQ in the trailing twelve months.

FDA records show no clearances under product code LDQ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LDQ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260