LATEX POWDER-FREE EXAMINATION GLOVES WITH COATING
Device Facts
| Record ID | K033789 |
|---|---|
| Device Name | LATEX POWDER-FREE EXAMINATION GLOVES WITH COATING |
| Applicant | Cardinalhealth |
| Product Code | LZC · General Hospital |
| Decision Date | May 7, 2004 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.6250 |
| Device Class | Class 1 |
Indications for Use
These examination gloves are disposable devices intended for medical purposes that are worn on the examiner's hands or fingers to prevent contamination between patient and examiner. In addition, these gloves are worn to protect the wearer against exposure to chemotherapy drugs. These latex gloves contain 50 micrograms or less of total water extractable protein per gram.
Device Story
Disposable latex patient examination glove; tan color; features proprietary coating containing Provitamin B, Gluconolactone, and Glycerol. Worn by clinicians/examiners to prevent cross-contamination between patient and examiner; provides barrier protection against chemotherapy drugs. Contains ≤50 micrograms/gram total water extractable protein. Powder-free; beaded cuff design.
Clinical Evidence
Bench testing only. Testing included primary skin irritation (no irritation), guinea pig maximization (no irritation potential), tensile strength (met ASTM D3578-01ae2), barrier defects (met 21 CFR 800.20 and ASTM D3578-01ae2), and chemotherapy drug permeation (ASTM F739-99a).
Technological Characteristics
Material: Latex. Coating: Proprietary blend of Provitamin B, Gluconolactone, and Glycerol. Form factor: Beaded cuff, powder-free. Standards: ASTM D3578-01ae2 (tensile strength, barrier defects), ASTM F739-99a (chemotherapy drug permeation).
Indications for Use
Indicated for use as a disposable patient examination glove worn on the examiner's hands or fingers to prevent cross-contamination between patient and examiner, and to protect the wearer against exposure to chemotherapy drugs.
Regulatory Classification
Identification
A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.
Predicate Devices
- Latex Powder-Free Examination Gloves (K033789)
Submission Summary (Full Text)
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MAY - 7 2004
Image /page/0/Picture/1 description: The image shows the logo for Cardinal Health. The logo consists of a stylized bird-like design above the company name. The bird design is made up of several curved lines that converge to a point, and the company name is written in a bold, sans-serif font.
# XIII. SUMMARY OF SAFETY AND EFFE
### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
Latex Powder-Free Examination Glove with tan color, proprietary coating (containing Provitamin B, Gluconolactone and Glycerol), protein labeling claim and chemotherapy labeling claim
Applicant/Sponsor: Cardinal Health 1500 Waukegan Road McGaw Park, IL 60085
Regulatory Affairs Contact: Erica Sethi Cardinal Health 1500 Waukegan Road, Bldg, WM McGaw Park, IL 60085
Telephone: (847) 785-3337
Date Summary Prepared: 5/4/04
Product Trade Name: Undetermined
Common Name: Examination Glove
Classification: Patient Examination Glove
Predicate Devices: Latex Powder-Free Examination Gloves
Description: Latex Powder-Free Examination Glove with tan color, proprietary coating (containing Provitamin B, Gluconolactone and Glycerol), protein labeling claim and chemotherapy labeling claim are formulated using Latex and offered powder-free.
Intended Use: These examination gloves are disposable devices intended for medical purposes that are worn on the examiner's hands or fingers to prevent contamination between patient and examiner. In addition, these gloves are worn to protect the wearer against exposure to chemotherapy drugs. These latex gloves contain 50 micrograms or less of total water extractable protein per gram.
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Substantial Equivalence: Latex Powder-Free Examination Glove with tan color, proprietary coating (containing Provitamin B, Gluconolactone and Glycerol), protein labeling claim and chemotherapy labeling claim are substantially equivalent to Cardinal Health's Latex Powder-Free Examination Gloves in that they provide the following characteristics:
- same intended use
- both made of Latex
- both offered beaded and powder-free
## Summary of Testing:
:
| Test | Result |
|-------------------------|-------------------------------------------------------------------------------|
| Primary Skin Irritation | Gloves show no irritation. |
| Guinea Pig Maximization | Gloves do not display any potential for irritation. |
| Tensile Strength | Gloves meet or exceed requirements per ASTM D3578-01ae2. |
| Barrier Defects | Gloves meet or exceed requirements per 21 CFR§800.20<br>and ASTM D3578-01ae2. |
| Chemotherapy testing | Tested for chemotherapy drugs using ASTM F739-99a |
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Image /page/2/Picture/1 description: The image is a black and white circular logo. The logo features the emblem of the U.S. Department of Health and Human Services. The emblem consists of a stylized eagle with three lines representing its wings, positioned within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY = 7 2004
Cardinal Health Ms. Erica Sethi Manager, Regulatory Affairs Medial Product and Services 1500 Waukegan Road Building WM McGaw Park, Illinois 60085-6787
Re: K033789
Trade/Device Name: Latex Powder-Free Examination Glove with Tan Color, Proprietary Coating (Containing Provitamin B, Gluconolactone and Glycerol), Protein Labeling Claim and Chemotherapy Labeling Claim Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZC Dated: April 8, 2004 Received: April 9, 2004
#### Dear Ms. Sethi:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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#### Page 2 - Ms. Sethi
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/4/Picture/0 description: The image shows the Cardinal Health logo. The logo consists of a stylized bird-like graphic above the text "CardinalHealth". The text is in a bold, sans-serif font.
Waukedan Road
Rem Mucey
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number_ K 033789
Page 1 of 1
Applicant:
Cardinal Health
510(k) Number:
<033789
Device Name: Latex Powder-Free Examination Glove with tan color, proprietary coating (containing Provitamin B, Gluconolactone and Glycerol), protein labeling claim and chemotherapy labeling claim
Indications For Use: A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. In addition, these gloves are worn to protect the wearer against exposure to chemotherapy drugs.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
or
Over-The Counter Use X
