510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K983182Substantially Equivalent

Aloe Therapy Oral Rinse

Carrington Laboratories, Inc., Crofton MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K983182 is the FDA 510(k) clearance record for ALOE THERAPY ORAL RINSE, cleared for Carrington Laboratories, Inc. on under FDA product code OLR (Oral Wound Dressing). FDA's definition for product code OLR reads: "Intended as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief. Unclassified status per SE to MGQ". FDA records list 15 510(k) clearances for Carrington Laboratories, Inc., from to . As of , FDA records show no recalls naming K983182.

Clearance record

Decision date
Received
(90 days to decision)
Product code
OLR Oral Wound Dressing
Device class
Unclassified
Review panel
Unknown
Applicant
Carrington Laboratories, Inc. P.O. Box 4341, Crofton MD
510(k) summary
Statement
Third party review
No

Clearances, product code OLR

Trailing 12 months
5 clearances under product code OLR in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code OLR, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20261
June 20261
July 20261
August 20261
September 20260
October 20260