Powder-Free Latex Exam Gloves with Protein Labeling (<50UG/G)
FDA 510(k) K014134 · Supergrade Healthcare Products Sdn. Bhd.
510(k) numberK014134
Submission
- Device name
- Powder-Free Latex Exam Gloves with Protein Labeling (<50UG/G)
- Applicant
- Supergrade Healthcare Products Sdn. Bhd.
Sparks, NV, US - Received
- December 17, 2001
- Decision date
- January 22, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
|---|---|---|---|
| K042618 | Laglove Brand Double Polymer Coated Nitrile Examination Gloves (Powder Free - Blue Color)FMC · Traditional | La Glove (M) Sdn. Bhd. | 11/26/2004SE |
| 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 |
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Questions and answers
When was Powder-Free Latex Exam Gloves with Protein Labeling (<50UG/G) cleared by the FDA?
Powder-Free Latex Exam Gloves with Protein Labeling (<50UG/G) (K014134) received a 510(k) decision of Substantially Equivalent on January 22, 2002, 36 days after the submission was received.
What is the product code of K014134?
The FDA product code is FMC – Patient Examination Glove, a Class I (low risk) device regulated under 21 CFR 880.6250.