NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CLAIM (50 MG OR LESS)

K111133 · Ssc Surat Thani · LYY · Jun 24, 2011 · General Hospital

Device Facts

• Record ID: K111133
• Device Name: NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CLAIM (50 MG OR LESS)
• Applicant: Ssc Surat Thani
• Product Code: LYY · General Hospital
• Decision Date: Jun 24, 2011
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A patient examination glove is a medical device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Device Story

Non-sterile, powder-free latex examination glove; protein content ≤ 50 micrograms. Device acts as a physical barrier to prevent cross-contamination between patients and healthcare examiners. Used in clinical settings; worn by medical professionals. Performance verified against ASTM D3578-2005 standards for dimensions, tensile strength, elongation, freedom from holes, and powder residue. Biocompatibility confirmed via skin irritation and sensitization testing. Provides protection for both patient and examiner during medical examinations.

Clinical Evidence

Bench testing only. Device performance validated against ASTM D3578-2005 (reapproved 2010) for dimensions, tensile strength, ultimate elongation, freedom from holes (AQL 2.5), powder-free residue, and protein levels (≤ 50 micrograms). Biocompatibility testing (primary skin irritation and guinea pig sensitization) passed per ISO 10993-10/2002.

Technological Characteristics

Latex material; powder-free. Dimensions, tensile strength, and elongation conform to ASTM D3578-2005 (reapproved 2010). Protein content ≤ 50 micrograms/g. Tested per ASTM D3767-03, ASTM D412-2006, ASTM D573-04, ASTM D6124-06, ASTM D5712-2010, and ASTM D5151-06. Biocompatibility per ISO 10993-10/2002. Non-sterile.

Indications for Use

Indicated for use as a disposable patient examination glove worn on the examiner's hand or finger to prevent contamination between patient and 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

• Sempermed Latex Patient Examination Glove, Powder free with protein claim (50 micrograms or less) (K100907)

Submission Summary (Full Text)

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510 (k) Summary

As Required by 21 section 807.92 ( c)

# KIII133

- 1. Submitter Name: SSC Surat Thani
JUN 2 4 2011

- 189 , Moo 7, Phaiwat , Kanjanadit, 2. Address: Suratthani, 84160, THAILAND
- ([phone]. Phone:
- ([phone]. Fax:

5. Contract Person: Mrs. Sureerat Choosri (Quality manager)

6. Date summary prepared: 1 Feb , 2011

Official Correspondent: Sempermed USA Inc. 7.

- 13900 49th Street North 8. Address: Clearwater, USA , FL 33762
- 727 787 7250 9. Phone:
- 727 787 7558 10. Fax:
- Mr. William E. Harris 11. Contact person:

12. Device Trade or Proprietary Name: Non-sterile, powder-free latex examination gloves with protein claim (50 micrograms or less).

13. Device Common or usual name: Examination glove

14. Device Classification Name: Glove , Patient Examination , Latex

15. Description of the Device:

15. Description of the Device:
Non-Sterile, powder-free latex examination gloves with protein claim (50 micrograms or less). 16. Indications for use of the device: Based on 21 CFR Part 880.6250: "Patient examination glove." A patient examination glove is a medical device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

17. Summary of The Technological Characteristics of The devices :(According Guidance for Industry and FDA Staff - Medical Glove Guidance Manual(January 22, 2008))

Non-Sterile, powder-free latex examination gloves with protein claim (50 micrograms or less) are summarized with the following technological characteristics:

| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE |
|-----------------------------------------------------------------|---------------------------------------|--------------------|
| Dimensions: overall length; width, palm<br>and finger thickness | ASTM D 3578-2005<br>(reapproved 2010) | Meets |
| Tensile strength: before and after aging | ASTM D 3578-2005<br>(reapproved 2010) | Meets |
| Ultimate elongation: before and after<br>aging | ASTM D 3578-2005<br>(reapproved 2010) | Meets |
| Freedom from holes: pinholes AQL 2.5 | ASTM D 3578-2005<br>(reapproved 2010) | Meets |
| Powder Free Residue | ASTM D 3578-2005<br>(reapproved 2010) | Meets |
| Protein Level | ASTM D 3578-2005<br>(reapproved 2010) | Meets |

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# K 111133

| Biocompatability | Primary Skin Irritation in<br>Rabbits<br>Guinea Pig Sensitization | Passes |
|------------------|-------------------------------------------------------------------|--------|
| | | Passes |

## 18. Substantial Equivalents Based on Assessment of Non-Clinical Performance Data

Stantial Equivalents Dased of the non-clinical tests that support a determination of substantial equivalence is the same as mentioned immediately above.

#### 19. Conclusion

It can be concluded that Non-Sterile, powder-free latex examination gloves with protein casting If can be concinded that Noll-Sterlic, powere not according to the glove performance standards referenced in section (50 micrograms of less) will perform according to the grows personemaly, this device is substantially I / above and meet ASTM standards, and ITA requirements. Sonse two predicate device Sizm equivalent to currently dialketed devices. I ms conver free with protein claim (0) micrograms or less).
Sempermed Latex Patient Examination Glove , Powder free with protein c Sempermed Lates I anem Exammation Giover expressed in the tabulated comparison as below.

Technical comparison of specific elements is attached in the main submission.

| FDA file reference number | 510k number : K100907 |
|--------------------------------------------------|----------------------------|
| Attachments inside notification submission file | REFER TO APPENDIX 1 |
| TECHNOLOGICAL CHARACTERISTICS | Comparison result |
| Indications for use | Identical |
| Target population | Identical |
| Design | Identical |
| Materials | Identical |
| Performance | Identical |
| Sterility | Not applicable |
| Biocompatibility | Identical |
| Mechanical safety | Identical |
| Chemical safety | Identical |
| Anatomical sites | Identical |
| Human factors | Identical |
| Energy used and/or delivered | Identical (Not applicable) |
| Compatibility with environment and other devices | Identical |
| Where used | Identical |
| Standards met | Identical |
| Electrical safety | Identical (Not applicable) |
| Thermal safety | Identical (Not applicable) |
| Radiation safety | Identical (Not applicable) |

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| K 111133 SSC Surat Thani | | | | | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DECLARATION OF CONFORMITY | | | | | |
| This is to declare and to confirm that SSC Surat Thani conforms in its manufacturing of Non-Sterile, powder-free latex examination gloves with protein claim (50 micrograms or less) to the<br>following recognized standards, latest released revisions. | | | | | |
| Standards met and standards tested against | Inapplicable<br>requirements<br>or deviations | Identification of any<br>way(s) in which the<br>standard was<br>adapted for the<br>application of the<br>device, i.e.,<br>identification of an<br>alternative series of<br>tests that were<br>performed | Specification of<br>any deviations<br>from each<br>applicable<br>standard | Specification of the differences<br>that may exist between the<br>tested device and the device to<br>be marketed and justification<br>of the test results | Name and address of any test laboratory or<br>certification body involved in determining the<br>conformance of the device with the standard<br>and reference to any accreditation of those<br>organization |
| Gloves: | | | | | |
| ASTM D 3578-05 (Reapproved 2010) | | | | | |
| Dimensions: overall length, width, palm and finger<br>thickness: ASTM D3578-05(Reapproved 2010)<br>Tested according to ASTM D3767-03(reapproved<br>2008) | | | Not applicable | | Siam Sempermed Laboratories in Thailand |
| Tensile strength & Ultimate elongation: before and<br>after aging: ASTM D3578-05 (Reapproved 2010)<br>Tested according to ASTM D 412-2006ae 2 and<br>ASTM D 573-04 (Reapproved 2010) | | | Not applicable | | Siam Sempermed Laboratories in Thailand |
| Donning support: ASTM D 3578-05 (Reapproved<br>2010) : Powder Free residue: Tested according to<br>ASTM D6124-06 | | | Not applicable | | Siam Sempermed Laboratories in Thailand |
| Water soluble Proteins: ASTM D 3578-05<br>(Reapproved 2010)<br>Tested according to ASTM D5712-2010 | | | Not applicable | | Siam Sempermed Laboratories in Thailand |
| Freedom from holes: ASTM D 3578-05<br>(Reapproved 2010)<br>Test according to ASTM D5151-06 | | | Not applicable | | Siam Sempermed Laboratories in Thailand |
| Sampling inspection: ISO 2859-1:1999/Cor<br>1:2001 | | | | | |
| Packages storage: ISO 2230-2002 | | | Not applicable | | |
| Supervision of product and design: QSR, MDD<br>directives 93/42 | | | Not applicable | | |
| Biocompatibility:<br>ISO 10993-10/2002 | | | | | Consumer Product Testing ,70 New Dutch<br>Lane , Fairfield, New Jersey , 07004-2514<br>Tel : [phone] Fax :[phone] |
| Name, Signature and Position | | | | | |

Swank

9. B

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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 features a stylized depiction of an eagle or bird-like figure with outstretched wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. William E. Harris President & CEO SSC Surat Thani 13900 49th Street North Clearwater, Florida 33762

JUN 2 4 2011

Re: K111133

Trade/Device Name: Non-Sterile Powder-Free Latex Examination Gloves with Protein Claim (50 Micrograms or Less) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: June 9, 2011 Received: June 9, 2011

Dear Mr. Harris:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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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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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.\

Sincerely vours,

Anthony D. mahr

Anthony D. Watson, B.S., M.S., M.B.A. 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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### Indications for Use

510(k) Number (if known):

Device Name: Non-Sterile, Powder-Free Latex Examination Glove with Protein Claim (50 micrograms or less).

Indications For Use: A patient examination glove is a disposable device intended for A patient oxamiles that is worn on the examiner's hand or finger medical purposes that on between patient and examiner.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

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

CZ

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

Elaine S. Mashall for Elizabeth Clavenie willians
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
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| 510(k) Number: | K111133 |
|----------------|---------|
|----------------|---------|