NON-STERILE, POWDERED, PINK LATEX EXAMINATION GLOVES WITH CHERRY FLAVOUR AND PROTEIN LABELING CLAIMS (200 UG OR LESS)

K072403 · Sgmp Co., Ltd. · LYY · Mar 27, 2008 · General Hospital

Device Facts

• Record ID: K072403
• Device Name: NON-STERILE, POWDERED, PINK LATEX EXAMINATION GLOVES WITH CHERRY FLAVOUR AND PROTEIN LABELING CLAIMS (200 UG OR LESS)
• Applicant: Sgmp Co., Ltd.
• Product Code: LYY · General Hospital
• Decision Date: Mar 27, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A medical glove to be worn on the hand of the health care and similar personnel to prevent contamination between health care personnel and patient.

Device Story

Non-sterile, powdered pink latex examination gloves; cherry-flavored; intended for use by healthcare personnel to prevent cross-contamination between examiner and patient. Device acts as a physical barrier. Manufactured to meet ASTM D3578-05 standards for latex examination gloves. Features protein labeling claims of 200 micrograms or less per square decimeter. Used in clinical settings to protect both patient and provider during examinations.

Clinical Evidence

Bench testing only. Testing included physical property evaluation (tensile strength, ultimate elongation), water leak testing (1,000 ml test per ASTM D3578-05), residual powder content (ASTM D6124-06), and residual protein levels (ASTM D5712-99). Results confirmed compliance with ASTM standards and FDA requirements for examination gloves.

Technological Characteristics

Latex material; powdered; cherry-flavored. Dimensions and physical properties (tensile strength, elongation) meet ASTM D3578-05. Residual powder content 5.2-8.5 mg/dm2 (ASTM D6124-06). Residual protein level <200 µg/dm2 (ASTM D5712-99). Non-sterile.

Indications for Use

Indicated for use by healthcare personnel as a disposable medical glove worn on the hand or finger to prevent cross-contamination between the patient and the examiner.

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

• POWDERED PINK LATEX EXAM GLOVES (K000671)

Submission Summary (Full Text)

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APPENDIX I

K072403

#### 510(k) SUMMARY

## SUMMARY OF THE SAFETY AND EFFECTIVENESS FOR POWDERED PINK LATEX EXAMINATION GLOVES WITH CHERRY FLAVOUR AND WITH PROTEIN LABELING CLAIMS (200 MICROGRAMS OR LESS)

Submitted For : SGMP Company Limited, 181 Moo 6, Tambol Kampaengpetch, Rattaphum, Songkhla 90180, Thailand.

Submitted By: Tucker & Associates Official Correspondent for SGMP Co Ltd Janna P. Tucker, President - CEO 198 Avenue de la D'emerald, Sparks, NV 89434-9550 Phone No : 775-342-2612 Fax No : 775-342-2613 E-mail: [e-mail]

Equivalent Predicate Device: POWDERED PINK LATEX EXAM GLOVES which was granted a 510(k) # K000671

This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.

#### Device Information:

Trade Name - Non-Sterile, Powdered Pink Latex Examination Gloves with Cherry Flavour and with protein labeling claims (200 Micrograms or less)

#### Common Name - Exam gloves

Classification Name - Patient examination glove (per 21 CFR 880.6250)

Classification Information - Class I Latex patient examination glove 80LYY, powdered and meeting all the requirements of ASTM-D3578-05 Standard Specification for Latex Examination Gloves for Medical Application.

#### Device Description:

Class I latex patient examination gloves 80LYY, powder free and meeting all the requirements of ASTM-D3578-05 Standard Specification for Latex Examination Gloves for Medical Application.

#### Intended Use of Device:

A medical glove to be worn on the hand of the health care and similar personnel to prevent contamination between health care personnel and patient.

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## Technological Characteristics of Device:

.

## 1. Dimension

| DIMENSION | ASTM D3578-05 | SGMP |
|--------------------|---------------------------------|--------------|
| X-Small | 70 mm +/- 10 mm | 70 - 80 mm |
| Small | 80 mm +/- 10 mm | 80 - 85 mm |
| Medium | 95 mm +/- 10 mm | 90 - 97 mm |
| Large | 111 mm +/- 10 mm | 105 - 111 mm |
| Length | 230 mm minimum<br>for all sizes | 240 mm |
| Thickness - Finger | 0.08 mm min | 0.13 mm min |
| Palm | 0.08 mm min | 0.10 mm min |

- 2. Physical Properties (ASTM-D3578-05 Standard Specification for Latex Exam Gloves) on Lot# 7037 ి.

| | TENSILE STRENGTH | | ULTIMATE ELONGATION | |
|--------------|------------------|------|---------------------|------|
| | ASTM-D3578-05 | SGMP | ASTM-D3578-05 | SGMP |
| | Mpa | Mpa | % | % |
| Before Aging | 18.0 | | 650 | |
| X-Small | | 23.5 | | 780 |
| Small | | 28.8 | | 920 |
| Medium | | 22.7 | | 835 |
| Large | | 25.5 | | 810 |
| After Aging | 14.0 | | 500 | |
| X-Small | | 21.8 | | 740 |
| Small | | 25.5 | | 850 |
| Medium | | 22.3 | | 780 |
| Large | | 23.8 | | 830 |
| | | | | |

:

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## 3. Water Tight Test

| Batch # | Size | Sample Size | Leak Status | Number Leaked |
|---------|---------|-------------|-------------|---------------|
| UN-AGED | | | | |
| 7037 | X-Small | 125 | Yes | 2 |
| 7037 | Small | 125 | Yes | 2 |
| 7037 | Medium | 125 | Yes | 1 |
| 7037 | Large | 125 | Yes | 2 |
| AGED | | | | |
| 7037 | X-Small | 125 | No | 0 |
| 7037 | Small | 125 | Yes | 3 |
| 7037 | Medium | 125 | Yes | 2 |
| 7037 | Large | 125 | Yes | 1 |

Using the FDA specified 1,000 ml water leak test, 125 pieces of each size of the gloves were tested and our results are as given below:

The above figures are within the ASTM D3578-05 requirements for latex exam gloves of 2.5% AQL.

#### Biocompatibility 4.

The bio-compatibility test results are as per attached in APPENDIX H and show that the gloves passed the tests for examination gloves.

## 5. Total Residual Powder Content & Presence of Cornstarch

| Test | FDA Requirement | Internal SGMP'S |
|---------------------------------------------|-----------------|--------------------------------------------------|
| Residual Powder Content<br>(ASTM D 6124-06) | 10 mg/ dm2 max | Range : 5.2 - 8.5 mg/ dm2<br>Mean : 7.5 mg / dm2 |

#### 6. Residual Protein Level.

| Test | FDA Allowable level | Claimed Level |
|----------------|---------------------|---------------|
| ASTM D 5712-99 | < 200 µg/ dm² | < 200 µg/ dm² |

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## Conclusion :-

The data presented indicate that the Non-Sterile, Powdered Pink Latex Examination Gloves with Cherry Flavour and with protein labeling claims (200 Micrograms or less)

1. meets/exceeds ASTM- D3578-05 Standard Specifications For Latex Examination Glove,

meets FDA pinhole requirements, 2.

3. meets the protein labeling claims level at <200 ug/ dm2

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a human figure embracing or supporting another, representing the department's mission of protecting and promoting the health and well-being of Americans.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# MAR 2 7 2008

SGMP Company Limited C/O Ms. Janna P. Tucker Official Correspondent Tucker & Associates 198 Avenue de la D'emerald Sparks, Nevada 89434-9550

Re: K072403

Trade/Device Name: Non-Sterile, Powdered Pink Latex Examination Gloves with Cherry Flavour and with Protein Labeling Claims (200 Micrograms or Less) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY

Dated: March 11, 2008 Received: March 13, 2008

Dear Ms. Tucker:

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. Tucker

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Qur

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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# INDICATION FOR USE STATEMENT

Applicant : SGMP Company Limited

510K NUMBER: K072 403

Device Name : Non-Sterile, Powdered Pink Latex Examination Gloves with Cherry Flavour and with Protein Labeling claims (200 Micrograms or less)

Indication For Use :

The Non-Sterile Powdered Pink Latex Examination Gloves with Cherry Flavour and with Protein Labeling claims (200 Micrograms or less) 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.

Prescription Use .. (Part 21 CFR 801.Subpart D)

AND / OR

Over-The-Counter........................
21 CFR 801 Subpart C

Concurrence of CDRH , Office of Device Evaluation (ODE)

Shule R. Murphy, 10
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K022403

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