510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K984039Substantially Equivalent

Cranberry Powder Free Latex Examination Gloves with Protein Content Labeling Claim (50 Micrograms or Lesss)

Cranberry (M) Sdn. Bhd., Ipoh Perak, MY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K984039 is the FDA 510(k) clearance record for CRANBERRY POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESSS), a class I device, cleared for Cranberry (M) Sdn. Bhd. on under FDA product code LYY (Latex Patient Examination Glove). FDA's definition for product code LYY reads: "A latex patient examination glove is a disposable device made of natural rubber latex that may or may not bear a trace amount of residual powder, and is intended to be worn on the hand for medical purposes to provide a barrier against...". FDA records list 4 510(k) clearances for Cranberry (M) Sdn. Bhd., from to . As of , FDA records show no recalls naming K984039.

Clearance record

Decision date
Received
(137 days to decision)
Product code
LYY Latex Patient Examination Glove
Regulation
21 CFR 880.6250
Device class
Class I
Review panel
General Hospital
Applicant
Cranberry (M) Sdn. Bhd. Lot 85, Jalan Portland,, Ipoh Perak, MY
510(k) summary
Statement
Third party review
No

Clearances, product code LYY

Trailing 12 months

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

FDA records show no clearances under product code LYY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LYY, 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