Product code LYY: 510(k) clearances and predicates

Product code LYY covers Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein. FDA lists 1954 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.

Clearance volume

1954 clearances on file under product code LYY. Counts by year:

Year	Clearances
2022	14
2023	2
2024	1
2025	1
2026 so far	0

Recent clearances

Newest LYY clearances in the FDA index, with applicant and decision date:

• K250069, Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein, applicant Comfort Rubber Gloves Industries Sdn. Bhd., decided 2025-04-29. FDA record
• K240266, Latex Examination Glove Powder Free (Ocean Blue and Natural White), applicant Sri Trang Gloves (Thailand) Public Company Limited, decided 2024-09-09. FDA record
• K230573, Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeling Claim (Contains 50 ug per dm2 of glove or less of Total Water Extractable Protein), applicant Kossan International Sdn Bhd, decided 2023-06-13. FDA record
• K223298, Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L), applicant Shandong Intco Medical Products Co, Ltd., decided 2023-02-22. FDA record
• K222612, Powder-Free Latex examination gloves, applicant Guangdong Kingfa Sci. & Tech.Co., Ltd., decided 2022-11-25. FDA record
• K221667, Non Sterile Powder Free Latex Examination Glove, applicant New Era Medicare Sdn. Bhd., decided 2022-10-28. FDA record
• K222348, JR MEDIC, applicant Jr Engineering & Medical Technologies (M) Sdn. Bhd., decided 2022-10-27. FDA record
• K221374, Disposable Medical Rubber Examination Gloves (XS/S/M/L/XL), applicant Hebei Titans Hongsen Medical Technology Co., Ltd., decided 2022-10-26. FDA record

What this means for a regulatory watcher

Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include Latex Examination Glove Powder Free (Ocean Blue and Natural White), Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeling Claim (Contains 50 ug per dm2 of glove or less of Total Water Extractable Protein). Watch new LYY clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.

FAQ

What is FDA product code LYY?

It is the three letter code FDA assigns to a device type in the 510(k) index. Recent LYY clearances include Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein.

How many 510(k) clearances use product code LYY?

1954 at the time this page was generated, from openFDA records.

How do I find a predicate device under LYY?

Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.

How do I track new LYY clearances?

Get 510(k) alerts filtered to this product code and read each new clearance as it posts.

Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.