NON-STERILE POWDER FREE PURPLE LATEX EXAMINATION GLOVE WITH BLUEBERRY SCENTED AND PROTEIN CONTENT CLAIM (50 MICROGRAMS O

K012857 · Sgmp Co., Ltd. · LYY · Sep 21, 2001 · General Hospital

Device Facts

• Record ID: K012857
• Device Name: NON-STERILE POWDER FREE PURPLE LATEX EXAMINATION GLOVE WITH BLUEBERRY SCENTED AND PROTEIN CONTENT CLAIM (50 MICROGRAMS O
• Applicant: Sgmp Co., Ltd.
• Product Code: LYY · General Hospital
• Decision Date: Sep 21, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Indications for Use

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

Device Story

Non-sterile, powder-free, purple latex examination gloves with blueberry scent. Designed for use by healthcare personnel to provide a protective barrier against contamination. Gloves are worn on the hands during patient examinations. Device performance is verified through water leak testing (ASTM D3578-00), tensile strength, and ultimate elongation measurements. Biocompatibility testing confirms safety for skin contact. Residual powder content and protein levels are controlled to meet specific safety standards (ASTM D6124-00 and ASTM D5712-95).

Clinical Evidence

Bench testing only. Testing included water leak tests (1,000 ml leak test per FDA requirements), tensile strength and ultimate elongation (before and after aging), residual powder content (ASTM D6124-00), and residual protein levels (ASTM D5712-95). Results confirmed compliance with ASTM D3578-00 standards and FDA pinhole requirements.

Technological Characteristics

Material: Latex. Form factor: Powder-free examination glove. Dimensions: 242mm length; 0.08mm minimum thickness. Standards: ASTM D3578-00 (physical properties), ASTM D6124-00 (residual powder), ASTM D5712-95 (protein content). Features: Purple color, blueberry scent. Sterilization: Non-sterile.

Indications for Use

Indicated for use by healthcare and similar personnel as a protective barrier to prevent cross-contamination between the wearer and the patient.

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.

Submission Summary (Full Text)

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## APPENDIX K

K0128

9/21/01

## 510(k) SUMMARY SUMMARY OF THE SAFETY AND EFFECTIVENESS FOR SUMMARY OF THE SALES I THE SALET I THE TIC EXAMINATION GLOVES

## Contact person : Ong Lay Mau

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

## Device Information:

Device Information:
Trade Name - POWDER FREE GREEN COLOR SYNTHETIC EXAM GLOVES

Common Name - Exam gloves

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

Classification Name - Patient examilation gover (per of or other 80LY ) remination Gloves for Medical Classification Information - Class I latex paned Cancification for Latex Examination Gloves for Medical the requirements of the elongation at break parameter.

## Device Description:

Device Description:
Class I latex patient examination glove 80LZA, powder free Modical Archicetion, executively of ASTM Class I latex patient examination grove 80224, power 1100 million Application, except for the elongation at break parameter.

## Intended Use of Device:

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.

Technological Characteristics of Device:

#### 1. Dimension

| DIMENSION | ASTM D3578-99 | Shield Gloves |
|-------------------------------------|-----------------------------------------------------------------------|--------------------------------------------------------|
| X-Small<br>Small<br>Medium<br>Large | 70 mm +/- 10 mm<br>80 mm +/- 10mm<br>95 mm +/- 10mm<br>111mm +/- 10mm | 70 - 75 mm<br>80 - 85 mm<br>90 - 97 mm<br>105 - 111 mm |
| Length | 230 mm minimum<br>for all sizes | 242mm |
| Thickness -<br>Finger<br>Palm | 0.08mm min<br>0.08mm min | 0.08 mm min<br>0.08 mm min |

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K012851

| | TENSILE STRENGTH | | ULTIMATE ELONGATION | |
|-------------------------------------------------------|------------------|-------------------------------------|---------------------|-------------------------------|
| | ASTM-D3578-00 | SGMP | ASTM-D3578-00 | SGMP |
| Before Aging<br>X-Small<br>Small<br>Medium<br>Large . | Mpa<br>14.0 | Mpa<br>25.3<br>26.0<br>28.9<br>22.0 | %<br>700 | %<br>840<br>850<br>860<br>840 |
| After Aging<br>X-Small<br>Small<br>Medium<br>Large | 14.0 | 21.3<br>23.4<br>23.6<br>21.7 | 500 | 890<br>930<br>940<br>900 |

### Physical Properties (ASTM-D3578-00 Standard Specification for Latex Exam Gloves) 2. on Lot# 1128

## 3. Water Tight Test

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:

| BATCH #<br>1128 | SIZE | SAMPLE SIZE | LEAK STATUS | NUMBER<br>LEAKED |
|-----------------|---------|-------------|-------------|------------------|
| UN-AGED | X-Small | 125 | Yes | 2 |
| | Small | 125 | No | 0 |
| | Medium | 125 | Yes | 1 |
| | Large | 125 | No | 0 |
| AGED | X-Small | 125 | Yes | 1 |
| | Small | 125 | Yes | 2 |
| | Medium | 125 | Yes | 1 |
| | Large | 125 | No | 0 |

The above figures are within the gloves of 2.5% AQL.

FDA/ASTM D3578-00 requirements for latex exam

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K012857

#### Biocompatibility 4.

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

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

| TESTS | FDA INTERNAL<br>REQUIREMENT | SGMP's |
|------------------------------------------------|-----------------------------|---------------------------------------------|
| Residual Powder<br>Content<br>(ASTM D 6124-00) | 2 mg/glove max | Range: 0.6-1.2g/glove<br>Mean : 0.9mg/glove |
| Presence of Cornstarch | Negative | Negative |

#### Residual Protein Level 6.

| TESTS | FDA ALLOWABLE LEVEL | CLAIMED LEVEL |
|----------------|--------------------------------------|--------------------------------------|
| ASTM D 5712-95 | < 50 $ \mu $ g/g | < 50 $ \mu $ g/g |

### Conclusion :-

The data presented indicate that the Non-sterile Powder Free Purple latex examination glove with blueberry scent

I. meets/exceeds ASTM- D3578-99 Standard Specifications For Latex Examination Glove,

2. meets FDA pinhole requirements,

meets FDA claim criterion of a powder free glove. 3.

meets the protein labeling claim level at <50 µg/g. 4.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The logo is black and white.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# SEP 2 1 2001

SGMP Company Limited C/O Ms. Janna P. Tucker Official Correspondent Tucker & Associates 198 Avenue De La D' Emerald Sparks, Nevada 89434

Re: K012857

Trade/Device Name: Non-Sterile Powder Free Purple Latex Examination Glove with Blueberry Scented and Protein Content Labeling Claim (50 Micrograms or Less) Regulation Number: 880.6250

Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: August 22, 2001 Received: August 24, 2001

#### 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 I least 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. or the rice of ally 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 (section 531-542 of the Act; 21): CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your 510(k) rine reter 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 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.

Sincerely yours.

Timoth 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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## INDICATION FOR USE STATEMENT

Applicant : SGMP Company Limited

10/2857 510K NUMBER :

Device Name : Non-sterile Powder Free Purple Latex Examination Gloves with Blueberry DEVEL HALLE PROFENT CONTENT LABELING CLAIM ( 50 MICROGRAMS OR LESS )

Indication For Use :

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

Concurrence of CDRH Office of Device Evaluation (ODE)

Prescription Use . Per 21 CFR 801.109 OR

2

Over-The-Counter ... .

Cl. Cl

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number _