Predicate Devices

Reference Devices

No reference devices were used in this submission.

AI/ML (Artificial Intelligence / Machine Learning)

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

Therapeutic

No.
Therapeutic devices are intended to treat or ameliorate a disease or condition. This device is an examination glove, which is intended to prevent contamination, not to treat any condition.

Diagnostic

No

The device is a patient examination glove used to prevent contamination, not to diagnose a condition.

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 to be worn on the examiner's hand to prevent contamination between patient and examiner. This is a barrier function, not a diagnostic test performed on a sample from the human body.
Device Description: The description focuses on the physical properties and standards met for a glove, not on any reagents, instruments, or software used for diagnostic purposes.
Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing information for diagnosis, monitoring, or treatment decisions based on in vitro testing.
Performance Studies: The performance studies listed (ASTM standards, biocompatibility) are related to the physical integrity, barrier properties, and safety of the glove for its intended use, not to diagnostic accuracy.

IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnostic purposes. This device is a physical barrier used during patient examination.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Cream Stretch Vinyl Patient Examination Glove (Non-Sterile) and White Vinyl Patient Examination Glove (Non-Sterile) are disposable devices intended for medical purposes that are worn on the examiner's hand to prevent contamination between patient and examiner. They are both sold as non-sterile.

Product codes

LYZ

Device Description

Cream Stretch Vinyl Patient Examination Glove (Non-Sterile) and White Vinyl Patient Examination Glove (Non-Sterile) are patient examination gloves available in S, M, L, XL. They are provided non-sterile and meet the entire requirement of ASTM standard D 5250-06, except for sterility requirements.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

examiner's hand

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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 following performance data were provided in support of the substantial equivalence determination.

ASTM D5250-06
ASTM D5151
Biocompatibility testing
The biocompatibility evaluation for the subject device was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing,"" May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The battery of testing included the following tests:
Cytotoxicity
Sensitization
Irritation

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

Cream Vinyl Patient Examination Glove (Non-Sterile):
- Dimension: Length 246mm, Width: S size = 85mm, M size = 95mm, L size = 105mm, XL size = 115mm, Finger thickness = 0.05mm, Palm thickness = 0.08mm. Meets ASTM D 5250-06
- Physical Properties: Tensile strength = 16.3MPa, Elongation = 391%. Meets ASTM D 5250-06
- Freedom from pinholes: Pinhole = 8/500, AQL 1.5. Meets ASTM D5151-06
- Powder Residual: Powder residue = 1mg. Meets ASTM D5250-06 and D6124-06
- Cytotoxicity (ISO10993-5): Passes
- Biocompatibility: Primary Dermal Irritation in rabbits - under the conditions of the study, not an irritant. Dermal Sensitization in the guinea pig – under conditions of the study; not a sensitizer.
White Vinyl Patient Examination Glove (Non-Sterile):
- Dimension: Length: 243mm, Width: S size = 85mm, M size = 95mm, L size = 105mm, XL size = 115mm, Finger thickness = 0.05mm, Palm thickness = 0.08mm. Meets ASTM D5250-06
- Physical Properties: Tensile strength = 15.7MPa, Elongation = 385%. Meets ASTM D 5250-06
- Freedom from pinholes: Pinhole = 10/500, AQL 1.5. Meets ASTM D5151-06
- Powder Residual: Powder residue = 1mg. Meets ASTM D5250-06 and D6124-06
- Cytotoxicity (ISO10993-5): Passes
- Biocompatibility: Primary Dermal Irritation in rabbits - under the conditions of the study, not an irritant. Dermal Sensitization in the guinea pig – under conditions of the study; not a sensitizer.

Predicate Device(s)

K100978

Reference Device(s)

No reference devices were used in this submission.

Predetermined Change Control Plan (PCCP) - All Relevant Information

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

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Image /page/0/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" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a series of interconnected human profiles.

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

July 29, 2015

Lifestyle Safety Products (Hui Zhou) Co., Ltd. c/o Ms. Rhonda Alexander, M.S. M.P.A Senior Regulatory Specialist Registrar Corp 144 Research Drive Hampton, VA 23666

Re: K143277

Trade/Device Name: Cream Stretch Vinyl Patient Examination Glove (Non-Sterile), White Vinvl Patient Examination Glove (Non-Sterile) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: June 3, 2015 Received: June 4, 2015

Dear Ms. Alexander:

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 devicerelated adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ReportaProblem/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 Industry and Consumer Education 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 yours.

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K143277

Device Name

Indications for Use (Describe)

The Cream Stretch Vinyl Patient Examination Glove (Non-Sterile) and White Vinyl Patient Examination Glove (Non-Sterile) are disposable devices intended for medical purposes that are worn on the examiner's hand to prevent contamination between patient and examiner. They are both sold as non-sterile.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

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510(k) Summary (21 CFR 807.92)

l. SUBMITTER

Lifestyle Safety Products (Hui Zhou) Co., Ltd Daxiaotang Village, Luoyang Town, Boluo County Hui Zhou City, Guang Dong Province, 516120 China

0086-0752-6863042 (phone) 0086-0752-6863392 (fax) Name of contact person: Mr. Lee Hong Chong Date the summary was prepared: September 9, 2014

II. DEVICE

Name of Device: Classification Name: Regulatory Class: Product Code:

Cream Stretch Vinyl Patient Examination Glove(Non-Sterile) White Vinyl Patient Examination Glove (Non-Sterile) Patient Examination Glove । LYZ

III. PREDICATE DEVICE

K100978: Powder-Free Non-Sterile Vinyl Examination Glove Manufactured by Jiangsu Sunshine Plastic Products, Co., Ltd

This predicate has not been subject to a design-related recall.

No reference devices were used in this submission.

IV. DEVICE DESCRIPTION

Cream Stretch Vinyl Patient Examination Glove (Non-Sterile) and White Vinyl Patient Examination Glove (Non-Sterile) are patient examination gloves available in S, M, L, XL. They are provided non-sterile and meet the entire requirement of ASTM standard D 5250-06, except for sterility requirements.

V. INDICATIONS FOR USE

The Cream Stretch Vinyl Patient Examination Glove (Non-Sterile) and White Vinyl Patient Examination Glove (Non-Sterile) are disposable devices intended for medical purposes that are worn on the examiner's hand to prevent contamination between patient and examiner. They are both sold as nonsterile.

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VI. SUMMARY OF COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

| Description | White Vinyl Patient
Examination Glove (Non-
Sterile) | Cream Stretch Vinyl
Patient Examination
Glove (Non-Sterile) | Predicate Device K100978 |
|--------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Disposable device
intended for medical
purposes that is worn on
the examiner's hand or
finger to prevent
contamination between
patient and examiner | Disposable device
intended for medical
purposes that is worn on
the examiner's hand or
finger to prevent
contamination between
patient and examiner | The 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. |
| Material | Poly Vinyl Chloride | Poly Vinyl Chloride | Poly Vinyl Chloride |
| Sizes | S, M, L, XL | S, M, L, XL | Information Unavailable |
| Single Use | Yes | Yes | Yes |
| Sterility | Non-sterile | Non-sterile | Non-sterile |

At a high level, the subject and predicate devices are based on the following same technological elements:

There are no significant technological differences between the subject and predicate devices:

| Characteristics Examination Glove (Non-
Sterile) Examination Glove
(Non-Sterile) performance |
|-------------------- | Dimension Width:
S size = 85mm
M size = 95mm
L size = 105mm
XL size = 115mm
Finger thickness = 0.05mm
Palm thickness = 0.08mm
Meets ASTM D S size = 85mm
M size = 95mm
L size = 105mm
XL size = 115mm
Finger thickness =
0.05mm Palm thickness
= 0.08mm
Meets ASTM D5250-06 | Physical Properties Elongation = 391%
Meets ASTM D 5250-06 15.7MPa
Elongation = 385%
Meets ASTM D 5250-06 | Freedom from pinholes AQL 1.5
Meets ASTM D5151-06 AQL 1.5
Meets ASTM D5151-06 | Powder Residual Meets ASTM D5250-06 and
D6124-06 Meets ASTM D5250-06
and D6124-06 | Cytotoxicity
(ISO10993-5) | Passes | Biocompatibility in rabbits - under the Irritation in rabbits - | Cream Vinyl Patient
| White Vinyl Patient
| Predicate Device
----------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|
| Length 246mm
5250-06 | Length: 243mm Width:
| Meets ASTM D 5250-06 |
| Tensile strength = 16.3MPa
| Tensile strength =
| Meets ASTM D 5250-06 |
| Pinhole = 8/500
| Pinhole = 10/500
| Meets 21 CFR 800.20 |
| Powder residue = 1mg
| Powder residue = 1mg
| Meets ASTM D6124-06 |
| Passes | N/A |
| Primary Dermal Irritation
| Primary Dermal
| Passes |

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| conditions of the study, not
an irritant. | under the conditions of
the study, not an
irritant. | |
|----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|--------|
| Dermal Sensitization in the
guinea pig – under
conditions of the study;
not a sensitizer. | Dermal Sensitization in
the guinea pig – under
conditions of the study;
not a sensitizer. | Passes |

VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

ASTM D5250-06 o
. ASTM D5151

Biocompatibility testing

The biocompatibility evaluation for the subject device was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing,"" May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The battery of testing included the following tests:

. Cytotoxicity
. Sensitization
Irritation .

The subject device is considered to be a surface device, contacting intact skin, for a duration of less than 24 hours.

VIII. CONCLUSIONS

Since there are minimal differences between the predicate device and the subject devices, we conclude that the subject devices perform comparably to the predicate device that is currently marketed for the same intended use.