Illusion Powder Free Exam Gloves, Natural Color with Vanilla Scent, Orange Color with Citric Scent and Pink Color
FDA 510(k) K083571 · Purna Bina Sdn Bhd
510(k) numberK083571
Submission
- Device name
- Illusion Powder Free Exam Gloves, Natural Color with Vanilla Scent, Orange Color with Citric Scent and Pink Color
- Applicant
- Purna Bina Sdn Bhd
Kluang, Johor, MY - Received
- December 3, 2008
- Decision date
- August 13, 2009
- 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.
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|---|---|---|---|
| K250069 | Powder Free Natural Rubber Latex Examination Gloves Blue, Non-Sterile and Protein…LYY · Traditional | Comfort Rubber Gloves Industries Sdn. Bhd. | 04/29/2025SE |
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| 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 |
|---|---|---|
| K130450 | Surgtex Powdered Surgical Glove, Surgtex Powderfree Polymer Coated Surgical GloveKGO · Traditional | 09/30/2014SE |
| K041004 | Illusion Powder Free-Polymer Coated Color Scented NR Latex Examination Gloves (Blue)LYY · Traditional | 07/02/2004SE |
| K022659 | Illusion Powder Free-Ploymer Coated Color Scented NR Latex Examination Gloves (Blue)LYY · Traditional | 09/25/2002SE |
| K003904 | Polymer Coated Powder Free Latex Examination GlovesLYY · Traditional | 01/24/2001SE |
| K994420 | Powder Free Latex Examination Patient GlovesLYY · Traditional | 09/18/2000SE |
| K891507 | Patient Examination Gloves (Latex)LYY · Traditional | 04/06/1989SE |
Questions and answers
When was Illusion Powder Free Exam Gloves, Natural Color with Vanilla Scent, Orange Color with Citric Scent and Pink Color cleared by the FDA?
Illusion Powder Free Exam Gloves, Natural Color with Vanilla Scent, Orange Color with Citric Scent and Pink Color (K083571) received a 510(k) decision of Substantially Equivalent on August 13, 2009, 253 days after the submission was received.
What is the product code of K083571?
The FDA product code is LYY – Latex Patient Examination Glove, a Class I (low risk) device regulated under 21 CFR 880.6250.