Patient Latex Examination Glove Powdered & Powder Free, Sterile
FDA 510(k) K992681 · Wear Safe Malaysia Sdn. Bhd.
510(k) numberK992681
Submission
- Device name
- Patient Latex Examination Glove Powdered & Powder Free, Sterile
- Applicant
- Wear Safe Malaysia Sdn. Bhd.
Port Klang, Selangor, D.E., MY - Received
- August 10, 1999
- Decision date
- December 16, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LYY – Latex Patient Examination Glove
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.6250
- Specialty
- General Hospital
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 potentially infectious materials and other contaminants.
Other 510(k)s with product code LYY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250069 | Powder Free Natural Rubber Latex Examination Gloves Blue, Non-Sterile and Protein…LYY · Traditional | Comfort Rubber Gloves Industries Sdn. Bhd. | 04/29/2025SE |
| K240266 | Latex Examination Glove Powder Free (Ocean Blue and Natural White)LYY · Abbreviated | Sri Trang Gloves (Thailand) Public Company Limited | 09/09/2024SE |
| K230573 | Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein…LYY · Traditional | Kossan International Sdn Bhd | 06/13/2023SE |
| K223298 | Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L)LYY · Traditional | Shandong Intco Medical Products Co, Ltd. | 02/22/2023SE |
| K222612 | Powder-Free Latex examination glovesLYY · Traditional | Guangdong Kingfa Sci. & Tech.Co., Ltd. | 11/25/2022SE |
| K221667 | Non Sterile Powder Free Latex Examination GloveLYY · Traditional | New Era Medicare Sdn. Bhd. | 10/28/2022SE |
| K222348 | JR MedicLYY · Abbreviated | Jr Engineering & Medical Technologies (M) Sdn.… | 10/27/2022SE |
| K221374 | Disposable Medical Rubber Examination Gloves (XS/S/M/L/XL)LYY · Traditional | Hebei Titans Hongsen Medical Technology Co., Ltd. | 10/26/2022SE |
| K222693 | Single-use medical latex examination gloves (LG100)LYY · Traditional | Fitone Latex Products Co., Ltd. Guangdong | 09/24/2022SE |
| K221648 | Iconic Latex GloveLYY · Traditional | Iconic Medicare Sdn Bhd | 08/25/2022SE |
More from Iconic Medicare Sdn Bhd
| 510(k) | Device | Decision |
|---|---|---|
| K172420 | Sterile Powder Free Nitrile Surgical Glove, White Colored. Tested for Use with…KGO · Traditional | 09/29/2017SE |
| K101799 | Powder Free Latex Examination Gloves Blue (Colored), Non-Sterile, with Protein Labeling…LYY · Traditional | 09/03/2010SE |
| K093500 | Powder Free Nitrile Examination Gloves, White (Non-Colored) or Blue (Colored), Non-SterileLZC · Traditional | 01/19/2010SE |
| K092492 | Powder Free Polymer Coated Latex Examination Gloves, Non-Sterile, with Protein Labeling…LYY · Traditional | 10/21/2009SE |
| K090066 | Powder Free Polymer Coated Latex Surgical Gloves, Sterile, with Protein Labeling Claim…KGO · Traditional | 05/15/2009SE |
| K090327 | Powder Free Polymer Coated Latex Examination Gloves, Sterile, with Protein Labeling…LYY · Traditional | 04/03/2009SE |
| K062917 | Sterile and Non-Sterile Powder-Free Latex Patient Examination Glove, with Extractable…LYY · Traditional | 11/02/2006SE |
| K062778 | Sterile Powder-Free Nitrile Patient Examination Glove, Blue ColoredLZA · Traditional | 10/27/2006SE |
| K992675 | Patient Nitrile Examination Gloves (Powdered)LZA · Traditional | 01/20/2000SE |
| K992676 | Patient Latex Examination Powder-Free Polymer Coated GlovesLYY · Traditional | 12/16/1999SE |
Questions and answers
When was Patient Latex Examination Glove Powdered & Powder Free, Sterile cleared by the FDA?
Patient Latex Examination Glove Powdered & Powder Free, Sterile (K992681) received a 510(k) decision of Substantially Equivalent on December 16, 1999, 128 days after the submission was received.
What is the product code of K992681?
The FDA product code is LYY – Latex Patient Examination Glove, a Class I (low risk) device regulated under 21 CFR 880.6250.