POWDER FREE HYPROALLERGENIC EXAMINATION GLOVE (WITH LOW PROTEIN CLAIM)

K974065 · Tillotson Healthcare Corp. · LYY · Jan 6, 1998 · General Hospital

Device Facts

• Record ID: K974065
• Device Name: POWDER FREE HYPROALLERGENIC EXAMINATION GLOVE (WITH LOW PROTEIN CLAIM)
• Applicant: Tillotson Healthcare Corp.
• Product Code: LYY · General Hospital
• Decision Date: Jan 6, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

This is a disposable device, intended for medical purposes, that is worn on the examiner's hand to prevent contamination between patient and examiner. Low protein claim surgical gloves are suitable in situations where healthcare worker or patient allergic sensitivity may be a factor. Powder free gloves are intended for use in situations where powder is not desirable.

Device Story

Disposable natural rubber latex examination glove; functions as physical barrier against body fluids and bloodborne pathogens. Designed for use by healthcare professionals in clinical settings to prevent cross-contamination. Manufactured via leaching process to remove chemical accelerants and reduce protein content; provides tensile strength and flexibility. Output is a protective hand covering; aids clinical decision-making by maintaining sterile/hygienic environment during patient examinations. Benefits patient and examiner by reducing exposure to pathogens and potential allergens.

Clinical Evidence

Bench testing only. Performance verified against ASTM D3578 (physical properties), ASTM D5151 (water tightness), and ASTM D5712 (protein content). Safety verified via rabbit irritation testing.

Technological Characteristics

Natural rubber latex material. Conforms to ASTM D3578 (physical properties), ASTM D5151 (water tightness), and ASTM D5712 (protein content). Manufacturing includes leaching process to remove chemical accelerants. Powder-free. Low protein claim (50 micrograms or less of total water extractable protein per gram).

Indications for Use

Indicated for use as a protective barrier on the examiner's hand to prevent contamination between patient and examiner. Suitable for use in clinical settings where low protein content is required due to allergic sensitivity or where powder-free conditions are preferred.

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

• Powder Free, Hypoallergenic Examination Glove (K974065)

Submission Summary (Full Text)

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K974065
JAN. 4, 1998

# SUMMARY OF 510(k) Submission # K97

- INFORMATION A.
- 1. SUBMITTER'S
- NAME:

ADDRESS:

TELEPHONE NUMBER:

CONTACT PERSON:

DATE SUMMARY PREPARED:

- 2. NAME OF DEVICE TRADE OR PROPRIETARY NAME:
COMMON OR USUAL NAME:

CLASSIFICATION NAME:

- 3. PREDICATE DEVICE IDENTIFICATION NAME, NUMBER
360 Route 101

TILLOTSON HEALTHCARE CORPORATION

Bedford, NH 03110 U.S.A.

[phone]

Edward Markovic

October 17, 1997

Powder Free, Examination Glove

Examination Glove

Examination Glove

1. Powder Free, Hype 1 1 4 1

Examination Glove KI (with low protein claim)

(which low protein grain)

- 4. DESCRIPTION OF DEVICE
- DESCRIF TION DEVICE FUNCTIONS: HOW THE DEVICE FUNCTIONS:
Natural Rubber Latex films form an excellent barrier to body fluids and bloodborne pathogens.
- b. SCIENTIFIC CONCEPTS THAT FORM THE BASIS FOR THE DEVICE:
- SCIENTIFIC CONCEPTS THAT FORM THE BADIC HONDANIA of use. It's tensile The latex rubber is water tight under normal concreases of ovements necessary for medical treatment.

PHYSICAL AND PERFORMANCE CHARACTERISTICS SUCH AS DESIGN, MATERIALS

| C. PHYSICAL AND PERFORMANCE |
|----------------------------------------------------------------------------------------|
| AND PHYSICAL PROPERTIES: |
| Natural Rubber Latex is known to create a superior barrier to bloodborne pathogens and |
| and body fluids. ASTM conforming tensile properties create a glove that is strong |
| and flexible. The leaching process removes traces of chemical accelerants that |
| may be chemically irritating. The glove is manufactured in accordance with the |
| requirements of ASTM D3578 and ASTM D5151 requirements. |

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#### SUMMARY OF SAFETY AND EFFECTIVENESS (cont.)

- 5. STATEMENT OF INTENDED USE, INCLUDING DESCRIPTION OF THE DISEASES OR conditions that the device will address

| This is a disposable device, intended for medical purposes, that is worn on<br>the examiner's hand to prevent contamination between patient and examiner. |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Low protein claim surgical gloves are suitable in situations<br>where healthcare worker or patient allergic sensitivity may be a factor. Powder free<br>gloves are intended for use in situations where powder is not desirable. |

- 6. EXPLANATION OF SIMILARITIES OR DIFFERENCES TO PREDICATE DEVICE

| . The proposed product is identical to the predicate product and is<br>The first of the country of the consisted on the consisted on the comments of the comments of the comments of the comments of the comments of the comments of the comments of |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| sultable for situations where a low sensitizing glove is desirable. |

- · It is powder free, (with low protein claim) in the same way as predicate product.
#### B. IF SE DECISION BASED ON PERFORMANCE DATA

- 1. DISCUSSION OF NON-CLINICAL TESTS
2.

| SPECIFICATION | PROPOSED | PREDICATE |
|----------------------------------------------|------------------------------|------------------------------------------------|
| | Powder Free<br>(low protein) | Powder Free<br>Hypoallergenic<br>(low protein) |
| PERFORMANCE<br>STANDARDS | ASTM D3578 | ASTM D3578 |
| WATER TIGHTNESS | ASTM D5151 | ASTM D5151 |
| PROTEIN | ASTM D5712 | ASTM D5712 |
| DISCUSSION OF CLINICAL TESTS | | |
| SPECIFICATION<br>SAFETY<br>RABBIT IRRITATION | Passes | Passes |

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## SUMMARY OF SAFETY AND EFFECTIVENESS (cont.)

### DISCUSSION OF SAFETY OR EFFECTIVENESS DATA OBTAINED with specific reference to adverse effects and complications

- 3. CONCLUSIONS DRAWN FROM NONCLINICAL AND CLINICAL TESTS THAT DEMONSTRATE CONCEGSIONS DRAWN PROM PERFORMANCE =/> PREDICATE PRODUCT
The Powder Free, Hypoallergenic Examination Glove has been carefuly compared The Powder Free, I rypocas in the 510(k). The data summaries indicate that the propolsed w again managed acceptable scores for the prodicate product in nonclinical tests, and satisfies the requirements for a safe and effective powder free, hypoallergenic medical glove.

Pursuant to 21 C.F.R. 807.87 ( ) ), I, Edward Markovic, Manager QA/Regulatory Affairs certify that to the best of my knowledge and belief and based upon the data and information submitted to me in the course of my responsibilities as the Manager QA/Regulatory Affairs for TILLOTSON HEALTHCARE CORPORATION. and in reliance thereupon, the data and information submitted in this premarket notification are truthful and accurate and that no facts material to a review of the substantial equivalence of this device have been knowingly omitted from this submission.

Edward Markovic Manager QA/Regulatory Affairs

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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN - 6 1998

Mr. Edward Markovic Manager Quality Assurance/Regulatory Affairs Tillotson Healthcare Corporation 360 Route 101 03110 Bedford, New Hampshire

K974065 Re : Powder Free Latex Examination Glove (with Trade Name: Protein Claim) 50 micrograms or less of total water extractable protein per gram Regulatory Class: I Product Code: LYY Dated: October 17, 1997 Received: October 27, 1997

Dear Mr. Markovic:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical General requlation (21 CFR Part 820) and that, Devices: through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does

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Page 2 - Mr. Markovic

not affect any obligation you might have under sections 531 not arrece any obangat for devices under the Electronic ciffough 542 or cho notrol provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 510 k) premarket notification. The FDA described in your tial equivalence of your device to a legally marketed predicate device results in a classification for your marketed predicate anits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Page 1 of 1

Device Name:

on Glove beling claim) h com ins 60 microarams or loss This glove com of total water extractable protein per gram.

510/k) 974065

Indications For Use:

The Powder Free, Examination Glove is "a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.". (21CFR 880.6250).

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| (Division Sign-Off) | | Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|----------------------------------------|---------|--------------------------------------------------------|---|
| Division of Dental, Infection Control, | | | |
| and General Hospital Devices | | | |
| 510(k) Number | V974065 | | |
| Prescription Use | | Over-The-Counter Use | X |

(Per 21 CFR 801.109)

.................

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Over-The-Counter Use X

(Optional Format 1-2-98)

REVISED Section B (2) INDICATIONS FOR USE NSO9001\REGUL\510KVK974086\KCLOR.XLS

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