NON-STERILE POWDER FREE LATEX EXAMINATION GLOVES WITH VANILLA AND PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
Device Facts
| Record ID | K012863 |
|---|---|
| Device Name | NON-STERILE POWDER FREE LATEX EXAMINATION GLOVES WITH VANILLA AND PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) |
| 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 |
Intended 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.
Device Story
Non-sterile, powder-free, vanilla-scented latex examination gloves; intended for use by healthcare personnel as a protective barrier to prevent cross-contamination between clinician and patient. Device functions as a physical barrier; manufactured from latex; meets ASTM D3578-00 standards for physical dimensions, tensile strength, and elongation. Tested for water-tightness (1,000 ml leak test) and residual protein levels (<50 µg/g). Vanilla scent added for user preference. Used in clinical settings to protect both patient and provider.
Clinical Evidence
Bench testing only. Testing included physical property evaluation (tensile strength, elongation) per ASTM D3578-00, water-tightness testing (1,000 ml leak test) showing results within 2.5% AQL, residual powder content (ASTM D6124-00) at 1.2 mg/glove, and residual protein levels (ASTM D5712-99) at <50 µg/g. Biocompatibility testing confirmed the device is safe for use as an examination glove.
Technological Characteristics
Latex examination glove; powder-free; vanilla-scented. Meets ASTM D3578-00 standards for dimensions (70-111mm width, 252mm length) and thickness (0.08mm min). Tensile strength and elongation properties verified per ASTM standards. Residual protein level <50 µg/g. Residual powder content <2 mg/glove.
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.
Related Devices
- K032294 — NON-STERILE, POWDER FREE ORANGE LATEX EXAMINATION GLOVES W/ OR WITHOUT ORANGE/VANILLA SCENTING PLUS A PROTEIN LABELING · Sgmp Co., Ltd. · Aug 28, 2003
- K012860 — POWDER-FREE LATEX EXAM GLOVES WITH CHOCOLATE SCENTING AND PROTEIN LABELING CLAIM (<50UG/G) · Sgmp Co., Ltd. · Sep 21, 2001
- K030994 — NON-STERILE ORANGE COLORED POWDERED LATEX PATINET EXAMINATION GLOVES WITH & WITHOUT ORANGE/VANILLA SCENTS · Sgmp Co., Ltd. · Jun 12, 2003
- K032293 — NON-STERILE, POWDER FREE GREEN LATEX EXAMINATION GLOVES WITH OR WITHOUT SOUR APPLE OR PEPPERMINT SCENTING PLUS A PROTEIN · Sgmp Co., Ltd. · Aug 28, 2003
- K052666 — NON-STERILE POWDER FREE NATURAL/GREEN LANO-E LATEX EXAM GLOVES, WITH OR WIHOUT CITRUS/PEPPERMINT SCENT PLUS A PROTEIN · Ascend Eagle, Inc. · Jan 25, 2006
Submission Summary (Full Text)
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K012863
# SEP 2 1 2001
#### APPENDIX M
## 510(k) SUMMARY
## SUMMARY OF THE SAFETY AND EFFECTIVENESS FOR POWDER FREE VANILLA SCENTED LATEX EXAMINATION GLOVES
## Contact person : Cheah Chor Hee
This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
## Device Information:
Trade Name - NON-STERILE POWDER FREE VANILLA SCENTED LATEX EXAM GLOVES
Common Name - Exam gloves
Classification Name - Patient examination glove (per 21 CFR 880.6250)
Classification Information - Class I latex patient examination glove 80LYY, powder free and meeting all the requirements of ASTM-D3578-00 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-D3578-00 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.
Technological Characteristics of Device:
| DIMENSION | ASTM D3578-00 | SGMP |
|-------------------------------------|-----------------------------------------------------------------------|--------------------------------------------------------|
| 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 | 252 mm |
| Thickness -<br>Finger<br>Palm | 0.08mm min<br>0.08mm min | 0.08 mm min<br>0.08 mm min |
#### 1. Dimension
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| | TENSILE STRENGTH | | ULTIMATE ELONGATION | |
|--------------|------------------|------|---------------------|------|
| | ASTM-D3578-00 | SGMP | ASTM-D3578-00 | SGMP |
| Before Aging | Mpa | Mpa | % | % |
| 14.0 | | 700 | | |
| X-Small | | 26.6 | | 870 |
| Small | | 27.5 | | 870 |
| Medium | | 23.2 | | 840 |
| Large | | 25.7 | | 860 |
| After Aging | | | | |
| 14.0 | | 500 | | |
| X-Small | | 21.8 | | 870 |
| Small | | 26.6 | | 950 |
| Medium | | 23.7 | | 910 |
| Large | | 24.4 | | 910 |
## 2. Physical Properties (ASTM-D3578-00 Standard Specification for Latex Exam Gloves) on Lot# 1123
## 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>1123 | SIZE | SAMPLE SIZE | LEAK STATUS | NUMBER<br>LEAKED |
|-----------------|---------|-------------|-------------|------------------|
| UN-AGED | | | | |
| | X-Small | 125 | Yes | 1 |
| | Small | 125 | Yes | 2 |
| | Medium | 125 | No | 0 |
| | Large | 125 | Yes | 2 |
| AGED | | | | |
| | X-Small | 125 | No | 0 |
| | Small | 125 | Yes | 1 |
| | Medium | 125 | Yes | 1 |
| | Large | 125 | Yes | 1 |
The above figures are within the draft FDA/ASTM D3578-00 requirements for latex exam gloves of 2.5% AQL.
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#### 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.
#### TESTS FDA INTERNAL SGMP's REQUIREMENT Range: 0.8-1.6mg/glove Residual Powder 2 mg/glove max Mean : 1.2 mg/glove Content (ASTM D 6124-00) Negative Presence of Cornstarch Negative
## 5. Total Residual Powder Content & Presence of Cornstarch
#### 6. Residual Protein Level
| TESTS | FDA ALLOWABLE LEVEL | CLAIMED LEVEL |
|----------------|---------------------|---------------|
| ASTM D 5712-99 | < 50 µg/g | < 50 µg/g |
#### Conclusion:-
The data presented indicate that the Non-sterile Powder Free Vanilla Scented latex examination glove
meets/exceeds ASTM- D3578-00 Standard Specifications For Latex Examination Glove, .
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- 2. meets FDA pinhole requirements,
- meets FDA claim criterion of a powder free glove. র প
- 4. meets the protein labeling claim level at <50 ug/g.
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#### DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. In the center of the seal is a stylized image of three people.
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: K012863
Trade/Device Name: Non-Sterile Powder Free Latex Examination Gloves with Vanilla 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 23, 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.
Please be advised that FDA's issuance of a substantial equivalence determination does not
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#### Page 2 - Ms. Tucker
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 (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) 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/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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## INDICATION FOR USE STATEMENT
Applicant : SGMP Company Limited
510K NUMBER : K. Ol 286 3
Device,Name : Non-sterile Powder Free Latex Examination Gloves with Vanilla Seent
AND PROTEIN CONTENT LABELING CLAIM | ED MICROGRAMS OC LE55' 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
Over-The-Counter .........
2
Qia S. lin
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Device 510(k) Number _
