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)
FDA 510(k) K230573 · Kossan International Sdn Bhd
510(k) numberK230573
Submission
- Device name
- 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
Klang, MY - Received
- March 1, 2023
- Decision date
- June 13, 2023
- 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 |
| 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 |
| K211601 | Powder Free Latex Examination Glove, Non-SterileLYY · Traditional | Wrp Asia Pacific Sdn. Bhd. | 08/22/2022SE |
More from Wrp Asia Pacific Sdn. Bhd.
| 510(k) | Device | Decision |
|---|---|---|
| K260794 | NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WITH LICORICE ROOT EXTRACT…LZA · Traditional | 08/18/2026SE |
| K252549 | Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Green), Tested for…LZA · Traditional | 01/13/2026SE |
| K232461 | Powder Free Nitrile Examination Glove, Pink Colored, Non-Sterile, Tested for Use with…LZA · Traditional | 11/14/2023SE |
| K191800 | Sterile Powder Free Nitrile Examination Glove, Blue Colored, with Non-Pyrogenic Labeling…LZA · Traditional | 09/16/2019SE |
| K190606 | Powder Free Nitrile Patient Examination Glove, Black Colored, Non-SterileLZA · Traditional | 05/28/2019SE |
| K183287 | Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Tested for Use…LZA · Traditional | 04/05/2019SE |
| K181857 | Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis…LZA · Traditional | 11/20/2018SE |
| K170397 | Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Polymer…LZA · Traditional | 07/10/2017SE |
| K151750 | Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Powder Free…LZA · Traditional | 08/03/2016SE |
| K160467 | Sterile Powder Free Nitrile Examination Gloves, Blue Colored. Tested For Use with…LZA · Traditional | 08/02/2016SE |
Questions and answers
When was 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) cleared by the FDA?
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) (K230573) received a 510(k) decision of Substantially Equivalent on June 13, 2023, 104 days after the submission was received.
What is the product code of K230573?
The FDA product code is LYY – Latex Patient Examination Glove, a Class I (low risk) device regulated under 21 CFR 880.6250.