Laglove Brand Double Polymer Coated Nitrile Examination Gloves (Powder Free - Blue Color)
FDA 510(k) K042618 · La Glove (M) Sdn. Bhd.
510(k) numberK042618
Submission
- Device name
- Laglove Brand Double Polymer Coated Nitrile Examination Gloves (Powder Free - Blue Color)
- Applicant
- La Glove (M) Sdn. Bhd.
Kajang Selangpr D.E., MY - Received
- September 27, 2004
- Decision date
- November 26, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FMC – Patient Examination Glove
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.6250
- Specialty
- General Hospital
Other 510(k)s with product code FMC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K014134 | Powder-Free Latex Exam Gloves with Protein Labeling (<50UG/G)FMC · Traditional | Supergrade Healthcare Products Sdn. Bhd. | 01/22/2002SE |
| K992337 | Blossom Powder Free Latex Examination Gloves with Protein Content Labeling Claim 50 MCGM…FMC · Traditional | Mexpo Intl., Inc. | 08/17/1999SE |
| K932405 | Nitrile Rubber Examination Gloves (Powered)FMC · Traditional | Safeskin Corp. | 05/18/1994SE |
| K932404 | Nitrile Rubber Powder-Free Examination GloveFMC · Traditional | Safeskin Corp. | 05/18/1994SE |
| K923175 | Surgical Instrument Kit, DisposableFMC · Traditional | Ulti-Med Intl., Inc. | 06/17/1993SE |
| K920649 | CompasepFMC · Traditional | Wilde-USA, Inc. | 07/23/1992SE |
| K915376 | Glasion VarnishFMC · Traditional | Sci-Pharm Scientific Pharmaceutical, Inc. | 01/22/1992SE |
| K905127 | Latex Glove Application and Removal SystemFMC · Traditional | Success Builders Intl., Inc. | 01/30/1991SE |
| K905109 | Patient Examination Glove/HypoallergenicFMC · Traditional | Tactyl Technologies, Inc. | 11/21/1990SE |
| K903746 | Comfit, Patient Examination GlovesFMC · Traditional | Wembley Rubber Products (M) Sdn Bhd | 09/05/1990SE |
More from Wembley Rubber Products (M) Sdn Bhd
| 510(k) | Device | Decision |
|---|---|---|
| K093335 | Laglove Brand Nitrile Examination Gloves, Powder Free, Non-Sterile (Pink Color)LZA · Traditional | 06/18/2010SE |
| K093193 | La Glove Brand Colored Latex Examination Gloves, Powder Free, Non Sterile (Pink/ Green/…LYY · Traditional | 06/08/2010SE |
| K092499 | Laglove Brand Colored Latex Examination Gloves Powdered, Non-Sterile (Pink/Green/Violet)LYY · Traditional | 11/20/2009SE |
| K092498 | Laglove Brand Nitrile Examination Gloves Powdered, Non Sterile (Pink Color)LZA · Traditional | 11/20/2009SE |
| K010863 | Laglove Brand Nitroprene Powder Free Examination Gloves (Made of Nitrile-Neoprene…LZA · Traditional | 05/03/2001SE |
| K010861 | Laglove Brand Colored Powdered Nitrile Examination Gloves(Green/Purple)LZA · Traditional | 04/03/2001SE |
| K010860 | Laglove Brand Colored Powder Free Nitrile Examination Gloves (Green/Purple)LZA · Traditional | 04/03/2001SE |
| K991950 | Laglove Brand Nitrile Surgical Glove-Sterile (Powder-Free)KGO · Traditional | 08/12/1999SE |
| K991949 | Laglove Brand Nitrile Surgical Glove-Sterile (Powdered)KGO · Traditional | 08/12/1999SE |
| K990883 | Laglove Brand Blue Cololred Nitrile Examination Glove (Powdered)LZA · Traditional | 08/10/1999SE |
Questions and answers
When was Laglove Brand Double Polymer Coated Nitrile Examination Gloves (Powder Free - Blue Color) cleared by the FDA?
Laglove Brand Double Polymer Coated Nitrile Examination Gloves (Powder Free - Blue Color) (K042618) received a 510(k) decision of Substantially Equivalent on November 26, 2004, 60 days after the submission was received.
What is the product code of K042618?
The FDA product code is FMC – Patient Examination Glove, a Class I (low risk) device regulated under 21 CFR 880.6250.