DYNAREX/TILLOTSON NON-STERILE POWDER FREE BLUE NITRILE PATIENT EXAM GLOVE FOR USE WITH CHEMOTHERAPY DRUGS

K081569 · Dynarex Corporation · LZA · Sep 12, 2008 · General Hospital

Device Facts

• Record ID: K081569
• Device Name: DYNAREX/TILLOTSON NON-STERILE POWDER FREE BLUE NITRILE PATIENT EXAM GLOVE FOR USE WITH CHEMOTHERAPY DRUGS
• Applicant: Dynarex Corporation
• Product Code: LZA · General Hospital
• Decision Date: Sep 12, 2008
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A patient examination glove is disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. In addition, these gloves are worn to protect the wearer against exposure to Chemotherapy Drugs.

Device Story

Disposable nitrile patient examination glove; worn by clinicians/examiners to prevent cross-contamination between patient and examiner; provides barrier protection against chemotherapy drugs. Device is non-sterile; powder-free; blue color. Used in clinical settings; operated by healthcare professionals. Performance verified via physical testing (dimensions, tensile strength, elongation, water leak) and chemical permeation testing per ASTM standards. Protects wearer from potential exposure to hazardous chemotherapy agents during handling.

Clinical Evidence

Bench testing only. No clinical data. Testing included dermal sensitization, primary skin irritation, permeation testing per ASTM D6978-05, water leak tests, dimensions, tensile strength (before/after aging), and ultimate elongation (before/after aging). All tests passed and met ASTM D6319-00ae3 requirements.

Technological Characteristics

Material: Nitrile. Form factor: Powder-free blue patient examination glove. Standards: ASTM D6319-00ae3, ASTM D6978-05 (chemotherapy permeation). Physical properties: 14 MPa tensile strength (pre/post aging), 500% ultimate elongation (pre-aging), 450% (post-aging). Non-sterile. Single-use.

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 for protection 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

• Non-Sterile Powder-Free Blue Nitrile Examination Glove (K042378)

Reference Devices

• Medline Powder-Free Blue Nitrile Examination Gloves

Submission Summary (Full Text)

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## SEP 1 2 2008

K081569

## Exhibit # 1

## 510(K) SUMMARY

Page 1 of 3

THIS SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION IS BEING SUBMITTED IN ACCORDANCE WITH THE REQUIREMENTS OF THE SAFE MEDICAL DEVICES ACT OF 1990.

| Submitter | Dynarex Corporation<br>10 Glenshaw Street<br>Orangeburg, NY 10962<br>USA<br>Phone: [phone]<br>Fax: [phone] |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Vijay Sachdev |
| Date of Summary | 05-12-2008 |
| Trade Name | Non-sterile Dynarex / Tillotson Nitrile Powder<br>Free Blue Patient Examination Glove, Tested<br>for use with Chemotherapy Drugs. |
| Common Name | Dynarex / Tillotson Nitrile Powder Free<br>Patient Examination Glove. |
| Classification Name | Dynarex / Tillotson Nitrile Powder Free<br>Patient Examination Glove |
| Predicate Device | Shijiazhuang Tillotson Rubber Products Co.,<br>Ltd., China<br>Non-Sterile Powder-Free Blue Nitrile<br>Examination Glove, (K042378). |
| Device Description/ Comparison | Classified by FDA's General and Plastic<br>Surgery Device panel as Class I, 21CFR<br>880.6250, Patient Examination Glove 80 LZA,<br>and meets all requirements of ASTM Standard<br>D6319-00a £3 |
| Intended Use | A patient examination glove is disposable<br>device intended for medical purpose that is<br>worn on the examiner's hand or fingers to<br>prevent contamination between patient and<br>examiner.<br>In addition, these gloves are worn to<br>protect the wearer against exposure to<br>Chemotherapy Drugs. |

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# 510(K) SUMMARY

Page 2 of 3

### Substantial Equivalence Discussion:

A powder free patient examination glove (Tested for Use with Chemotherapy Drugs) is substantially equivalent to the predicate devices.

| Characteristic and | Dynarex Corporationn<br>(New Device) | Shijiazhuang Tillotson<br>Rubber Products Co., | MEDLINE |
|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| parameters | | | |
| Product Code | LZA | LZA | LZA |
| Intended Use | A patient examination<br>glove is disposable<br>device intended for<br>medical purpose that is<br>worn on the examiner's<br>hand or fingers to prevent<br>contamination between<br>patient and examiner. In<br>addition, these gloves are<br>worn to protect the<br>wearer against exposure<br>to Chemotherapy Drugs. | A patient examination<br>glove is disposable<br>device intended for<br>medical purpose that<br>is worn on the<br>examiner's hand or<br>fingers to prevent<br>contamination<br>between patient and<br>examiner. | Medline Powder-Free<br>Blue Nitrile<br>Examination Gloves<br>(Tested for Use with<br>Chemotherapy Drugs)<br>is a disposable device<br>intended for medical<br>purposes that is worn<br>on the examiner's<br>hand or finger to<br>prevent contamination<br>between patient and<br>examiner. |
| Width (size<br>medium) | 96 mm | 96 mm | 92 mm |
| Overall length | 230 mm | 230 mm | 240 mm |
| Palm thickness | 0.08 mm | 0.08 mm | 0.17 mm |
| Finger thickness | 0.08 mm | 0.08 mm | 0.18 mm |
| Tensile strength<br>pre aging min | 14 Mpa | 14 Mpa | 21 mpa |
| Tensile strength<br>after aging min | 14 Mpa | 14 Mpa | 16 mpa |
| Ultimate<br>elongation pre<br>aging min | 500 % | 500 % | 500 % |
| Ultimate<br>elongation after<br>aging min | 450 % | 450 % | 500 |
| Meets<br>Biocompatibility<br>standards | Yes | Yes | Yes |
| Duration of bio-<br>compatibility | Limited | Limited | Limited |
| Skin irritation test | Passes | Passes | Passes |
| Dermal<br>sensitization | Passes | Passes | Passes |
| Residual powder<br>test | Passes | Passes | Passes |

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# 510(K) SUMMARY

Page 3 of 3

Passes

#### Summary of Testing: Test Results 1. Dermal Sensitization Test

-
- 2. Primary Skin irritation
- 3. Permeation testing per ASTM D 6978-05
- 4. Water Leak Test
- 5. Dimensions (Length, Width, & Thickness) Test
- 6. Tensile strength (Before & after aging)

7. Ultimate elongation (Before & after aging)

Passes Passes Passes Passes Gloves meets the requirements of ASTM D6319-00ae3. Gloves meets the requirements of ASTM D6319-00ae3

The standards used by Dynarex Corporation to determine substantial equivalence are based on ASTM D 6319-00ae3-2001. All testing meets requirements for physical specifications and dimensions conducted on gloves, Inspection level S-2, AQL 4.0 pinholes at AQL 2.5

There are special labeling claims "Tested for Chemotherapy". We do not claim our gloves to be hypoallergenic.

#### Conclusion:

Powder free Blue Nitrile Patient Examination Glove tested with chemotherapy drugs performance was equivalent to any other conventional method evaluation concluded that our device raises no new issues of Safety and effectiveness.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. To the left of the bird is a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

SEP 1 2 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Vijay Sachdev Quality Engineer Dynarex Corporation 10 Glenshaw Street Orangeburg, New York 10962

Re: K081569

Trade/Device Name: Non-Sterile Dynarex / Tillotson Nitrile Powder Free Blue Patient Examination Glove, Tested for Use with Chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: August 18, 2008 Received: August 21, 2008

Dear Mr. Sachdev:

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 - Mr. Sachdev

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 (OS) 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

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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### Attachment 'A'

#### Indications for Use

510(k) Number (if known):

Device Name: Non-sterile Dynarex / Tillotson Nitrile Powder Free Blue Patient Examination Glove, Tested for use with Chemotherapy Drugs.

Indications For Use:

.

A patient examination glove is disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner.

These gloves are tested for use with Chemotherapy Drugs.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use __ X (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of

Shula A Murphy
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K081569