Patient Examination Glove
FDA product code FMC · Class I (low risk) · 21 CFR 880.6250 · General Hospital
34510(k) clearances
0PMA approvals
0recalls
Manufacturers
- Safeskin Corp. 2
- Jamar Health Products 2
- Phoenix Glove Co. 2
- Pollak (Intl.), Ltd. 2
- Abco Dealers, Inc. 1
- La Glove (M) Sdn. Bhd. 1
- A & A Medical, Inc. 1
- Daw Shin Industrial Co., Ltd. 1
- Sukas Export 1
- B Und J Instruments 1
- Marwood Medical, Inc. 1
- Packaging Technologies, Inc. 1
- Currie Medical Specialties, Inc. 1
- Ansell, Inc. 1
- American Hospital Supply Corp. 1
- American Medical Disposable, Inc. 1
- Associated Medical Products Co. 1
- Sterile Design, Inc. 1
- Conphar, Inc. 1
- Arbrook Mfg. Corp. 1
510(k) clearances
| 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 |
| 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 |
| K902278 | PVC Patient Examination GloveFMC · Traditional | Fujian Province Jiu Zhou Group | 08/29/1990SE |
| K883805 | Rocket Sex Crime KitFMC · Traditional | A & A Medical, Inc. | 01/31/1989SE |
| K885346 | Non-Sterile Vinyl GlovesFMC · Traditional | Daw Shin Industrial Co., Ltd. | 01/18/1989SE |
| K882533 | Latex Examination GloveFMC · Traditional | Sukas Export | 07/21/1988SE |
| K882583 | Latex Exam Gloves, Non-SterileFMC · Traditional | B Und J Instruments | 07/14/1988SE |
| K840620 | Tpn/Cvp Dressing Change KitFMC · Traditional | Marwood Medical, Inc. | 05/30/1984SE |
| K833758 | P.T.I. Dressing Change TraysFMC · Traditional | Packaging Technologies, Inc. | 01/26/1984SE |
| K831964 | CMS 2000 Series TPN KitsFMC · Traditional | Currie Medical Specialties, Inc. | 08/11/1983SE |
| K831564 | Orthopedic Surgical GloveFMC · Traditional | Ansell, Inc. | 07/12/1983SE |
| K821043 | Sterile Patient Exam. GlovesFMC · Traditional | Phoenix Glove Co. | 05/21/1982SE |
| K821028 | Finger CotsFMC · Traditional | Abco Dealers, Inc. | 04/26/1982SE |
| K802386 | Suture Wound Tray Milford WhittinsvilleFMC · Traditional | American Medical Disposable, Inc. | 11/12/1980SE |
| K802375 | Ampco Skin Scrub TrayFMC · Traditional | Associated Medical Products Co. | 10/10/1980SE |
| K801998 | Sterile Examination Glove #5121-5126FMC · Traditional | Pollak (Intl.), Ltd. | 09/09/1980SE |
| K801997 | Embossed Disp. Poly. Gloves #5101-03FMC · Traditional | Pollak (Intl.), Ltd. | 09/09/1980SE |
| K791738 | Custom Dressing Change TraysFMC · Traditional | Sterile Design, Inc. | 10/02/1979SE |
| K791805 | Conphar Exam. Gloves, PolyethyleneFMC · Traditional | Conphar, Inc. | 10/01/1979SE |
| K781820 | Gloves, Vinyl ExaminationFMC · Traditional | Phoenix Glove Co. | 12/07/1978SE |
| K781278 | Gloves, ProcedureFMC · Traditional | Arbrook Mfg. Corp. | 08/31/1978SE |
| K772336 | Glove & Latex Finger CotsFMC · Traditional | Jamar Health Products | 01/26/1978SE |
| K771757 | Exam GlovesFMC · Traditional | Jamar Health Products | 10/13/1977SE |
| K771673 | Catheteo Care Tray #0242FMC · Traditional | Concord Laboratories, Inc. | 09/30/1977SE |
| K770479 | Laceration KitFMC · Traditional | American Hospital Supply Corp. | 04/29/1977SE |