Comfit (Powder Free Examination Gloves (Hypoallergenic, Low Protein, Beaded)
FDA 510(k) K953213 · Wembley Rubber Products (M) Sdn Bhd
510(k) numberK953213
Submission
- Device name
- Comfit (Powder Free Examination Gloves (Hypoallergenic, Low Protein, Beaded)
- Applicant
- Wembley Rubber Products (M) Sdn Bhd
Salak Tinggi, Sepang Selangor, MY - Received
- July 10, 1995
- Decision date
- October 11, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
|---|---|---|
| K982600 | Profeel Synthetic Copolymer Surgical Gloves (Powdered)KGO · Traditional | 03/12/1999SE |
| K972616 | Oncology Plus Powder Free Latex Examination Gloves (Protein Content Labeling)LYY · Traditional | 01/27/1999SE |
| K972615 | Chemo Plus Powder Free Blue Latex Examination Gloves (Protein Content Labeling)LYY · Traditional | 01/26/1999SE |
| K972621 | Profeel Powder Free Surgical Gloves (Protein Content Labeling)KGO · Traditional | 10/24/1997SE |
| K962189 | Comfit Powder Free Green Examination Gloves (Hypoallergenic, Low Protein)LYY · Traditional | 07/26/1996SE |
| K962188 | Comfit Powder Free Blue Examination Gloves (Hypoallergenic, Low Protein)LYY · Traditional | 07/26/1996SE |
| K953590 | ComfitLYY · Traditional | 06/27/1996SE |
| K960178 | Comfit Brown, Beaded Surgeon's Gloves (Powdered, Hypoallergenic)KGO · Traditional | 05/06/1996SE |
| K960416 | Comfit MicropticKGO · Traditional | 04/26/1996SE |
| K960407 | Comfit OrthopedicKGO · Traditional | 04/26/1996SE |
Questions and answers
When was Comfit (Powder Free Examination Gloves (Hypoallergenic, Low Protein, Beaded) cleared by the FDA?
Comfit (Powder Free Examination Gloves (Hypoallergenic, Low Protein, Beaded) (K953213) received a 510(k) decision of Substantially Equivalent on October 11, 1996, 459 days after the submission was received.
What is the product code of K953213?
The FDA product code is LYY – Latex Patient Examination Glove, a Class I (low risk) device regulated under 21 CFR 880.6250.