Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical and material properties of examination gloves, with no mention of AI or ML.

Therapeutic

No.
The device (patient examination glove) is intended to prevent contamination between patient and examiner, not to treat or alleviate a disease or condition.

Diagnostic

No

Explanation: The device is a patient examination glove, intended to prevent contamination between patient and examiner. It does not perform any diagnostic function.

SaMD (Software as a Medical Device)

No

The device is a physical examination glove, which is a hardware medical device, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is clearly stated as a "disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner." This describes a barrier device used during physical examination, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
Device Description: The description is for a "Non-Sterile, powder-free latex examination gloves." This is a physical barrier, not a reagent, instrument, or system intended for in vitro use.
Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information
- Using reagents or analytical methods

The information provided aligns with the description of a Class I medical device (examination glove) used for barrier protection during patient contact.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

LYY

Device Description

Non-Sterile, powder-free latex examination gloves with protein claim (50 micrograms or less).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

hand or finger

Indicated Patient Age Range

Not Found

Intended User / Care Setting

examiner

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The device was tested against specific characteristics and standards for dimensions, tensile strength, ultimate elongation, freedom from holes, powder free residue, protein level, and biocompatibility, and "Meets" or "Passes" these standards.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K100907

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 880.6250 Non-powdered patient examination glove.

(a)
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.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.

Summary

0

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
(+66) 77 277888 3. Phone:
(+66) 77 277889 4. Fax:

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

Device Trade or Proprietary Name: Non-sterile, powder-free latex examination gloves with protein claim (50 micrograms or less).
Device Common or usual name: Examination glove
Device Classification Name: Glove , Patient Examination , Latex
Description of the Device:
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.
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
and finger thickness	ASTM D 3578-2005
(reapproved 2010)	Meets
Tensile strength: before and after aging	ASTM D 3578-2005
(reapproved 2010)	Meets
Ultimate elongation: before and after
aging	ASTM D 3578-2005
(reapproved 2010)	Meets
Freedom from holes: pinholes AQL 2.5	ASTM D 3578-2005
(reapproved 2010)	Meets
Powder Free Residue	ASTM D 3578-2005
(reapproved 2010)	Meets
Protein Level	ASTM D 3578-2005
(reapproved 2010)	Meets

1

K 111133

| Biocompatability | Primary Skin Irritation in
Rabbits
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)

2

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
following recognized standards, latest released revisions.
Standards met and standards tested against	Inapplicable
requirements
or deviations	Identification of any
way(s) in which the
standard was
adapted for the
application of the
device, i.e.,
identification of an
alternative series of
tests that were
performed	Specification of
any deviations
from each
applicable
standard	Specification of the differences
that may exist between the
tested device and the device to
be marketed and justification
of the test results	Name and address of any test laboratory or
certification body involved in determining the
conformance of the device with the standard
and reference to any accreditation of those
organization
Gloves:
ASTM D 3578-05 (Reapproved 2010)
Dimensions: overall length, width, palm and finger
thickness: ASTM D3578-05(Reapproved 2010)
Tested according to ASTM D3767-03(reapproved

                                                                                             |                                               |                                                                                                                                                                                                         | Not applicable                                                            |                                                                                                                                                           | Siam Sempermed Laboratories in Thailand                                                                                                                                                                    |

| Tensile strength & Ultimate elongation: before and
after aging: ASTM D3578-05 (Reapproved 2010)
Tested according to ASTM D 412-2006ae 2 and
ASTM D 573-04 (Reapproved 2010) | | | Not applicable | | Siam Sempermed Laboratories in Thailand |
| Donning support: ASTM D 3578-05 (Reapproved
2010) : Powder Free residue: Tested according to
ASTM D6124-06 | | | Not applicable | | Siam Sempermed Laboratories in Thailand |
| Water soluble Proteins: ASTM D 3578-05
(Reapproved 2010)
Tested according to ASTM D5712-2010 | | | Not applicable | | Siam Sempermed Laboratories in Thailand |
| Freedom from holes: ASTM D 3578-05
(Reapproved 2010)
Test according to ASTM D5151-06 | | | Not applicable | | Siam Sempermed Laboratories in Thailand |
| Sampling inspection: ISO 2859-1:1999/Cor
1:2001 | | | | | |
| Packages storage: ISO 2230-2002 | | | Not applicable | | |
| Supervision of product and design: QSR, MDD
directives 93/42 | | | Not applicable | | |
| Biocompatibility:
ISO 10993-10/2002 | | | | | Consumer Product Testing ,70 New Dutch
Lane , Fairfield, New Jersey , 07004-2514
Tel : 973 808 7111 Fax :973 808 7234 |
| Name, Signature and Position | | | | | |

Swank

B

3

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.

4

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 (800) 638-2041 or (301) 796-7100 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

5

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
Page 1 of 1

510(k) Number:	K111133
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