(257 days)
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.
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.
This document describes the marketing authorization for examination gloves, not an AI/ML powered medical device. Therefore, the information regarding acceptance criteria, study details, and related elements specific to AI/ML device evaluations outlined in the request cannot be extracted from this document.
The document primarily focuses on demonstrating substantial equivalence of the "Cream Stretch Vinyl Patient Examination Glove (Non-Sterile)" and "White Vinyl Patient Examination Glove (Non-Sterile)" to a predicate device (K100978: Powder-Free Non-Sterile Vinyl Examination Glove).
Here's the relevant information that can be extracted, pertaining to the glove, not an AI device:
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristics | Acceptance Criteria (from ASTM D5250-06, D5151-06, D6124-06, 21 CFR 800.20 or N/A) | Cream Stretch Vinyl Patient Examination Glove (Non-Sterile) Performance | White Vinyl Patient Examination Glove (Non-Sterile) Performance | Remarks |
|---|---|---|---|---|
| Dimension | Meets ASTM D 5250-06 | Length 246mm, Width: S=85mm, M=95mm, L=105mm, XL=115mm, Finger thickness = 0.05mm, Palm thickness = 0.08mm | Length: 243mm, Width: S=85mm, M=95mm, L=105mm, XL=115mm, Finger thickness = 0.05mm, Palm thickness = 0.08mm | Both subject devices meet ASTM D 5250-06 |
| Physical Properties | Meets ASTM D 5250-06 | Tensile strength = 16.3MPa, Elongation = 391% | Tensile strength = 15.7MPa, Elongation = 385% | Both subject devices meet ASTM D 5250-06 |
| Freedom from pinholes | Meets 21 CFR 800.20 (AQL 1.5 per ASTM D5151-06) | Pinhole = 8/500, AQL 1.5 | Pinhole = 10/500, AQL 1.5 | Both subject devices meet ASTM D5151-06 |
| Powder Residual | Meets ASTM D6124-06 (and D5250-06) | Powder residue = 1mg | Powder residue = 1mg | Both subject devices meet ASTM D5250-06 and D6124-06 |
| Cytotoxicity (ISO10993-5) | Passes | Passes | Passes | Evaluated as per ISO 10993-5 |
| Biocompatibility - Primary Dermal Irritation | Not an irritant | Under the conditions of the study, not an irritant. | Under the conditions of the study, not an irritant. | Conducted on rabbits, in accordance with FDA Blue Book Memo #G95-1 and ISO 10993-1 |
| Biocompatibility - Dermal Sensitization | Not a sensitizer | Under conditions of the study, not a sensitizer. | Under conditions of the study, not a sensitizer. | Conducted on guinea pig, in accordance with FDA Blue Book Memo #G95-1 and ISO 10993-1 |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Sizes:
- Pinhole: 500 gloves for each device type (Cream Stretch and White Vinyl).
- Other tests (Dimensions, Physical Properties, Powder Residual, Biocompatibility) do not specify the exact sample size in this summary, but indicate compliance with ASTM standards which would define sample sizes.
- Data Provenance: Not explicitly stated beyond "provided in support of the substantial equivalence determination." This implies the tests were conducted by the manufacturer, Lifestyle Safety Products (Hui Zhou) Co., Ltd., which is based in China. The data would be derived from laboratory testing of the manufactured gloves. The document does not specify if the testing was retrospective or prospective in the context of an FDA submission, but it is typically prospective testing performed on representative samples for premarket submissions.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable. For physical and biocompatibility testing of medical gloves, "ground truth" is established by adherence to recognized international and national standards (e.g., ASTM standards, ISO 10993). The results are objective measurements and expert consensus is not typically required in the same way it would be for an AI diagnostic algorithm.
4. Adjudication method for the test set:
Not applicable. Testing involves objective measurements against established standard criteria, not subjective interpretations requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is for an examination glove, not an AI/ML powered device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is for an examination glove, not an AI/ML powered device.
7. The type of ground truth used:
The "ground truth" for the device's performance is based on objective measurements obtained through laboratory testing against established international and national standards (e.g., ASTM D5250-06, ASTM D5151-06, ASTM D6124-06, ISO 10993-1, ISO 10993-5, 21 CFR 800.20) for medical devices, specifically patient examination gloves.
8. The sample size for the training set:
Not applicable. This is for an examination glove; there is no "training set" in the context of AI/ML.
9. How the ground truth for the training set was established:
Not applicable. There is no training set for this type of device.
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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
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)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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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 PatientExamination Glove (Non-Sterile) | Cream Stretch VinylPatient ExaminationGlove (Non-Sterile) | Predicate Device K100978 |
|---|---|---|---|
| Intended Use | Disposable deviceintended for medicalpurposes that is worn onthe examiner's hand orfinger to preventcontamination betweenpatient and examiner | Disposable deviceintended for medicalpurposes that is worn onthe examiner's hand orfinger to preventcontamination betweenpatient and examiner | The patient examinationglove is a disposabledevice intended formedical purposes that iswornon the examiner's hand orfinger to preventcontamination betweenpatient 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 | Cream Vinyl PatientExamination Glove (Non-Sterile) | White Vinyl PatientExamination Glove(Non-Sterile) | Predicate Deviceperformance |
|---|---|---|---|
| Dimension | Length 246mmWidth:S size = 85mmM size = 95mmL size = 105mmXL size = 115mmFinger thickness = 0.05mmPalm thickness = 0.08mmMeets ASTM D 5250-06 | Length: 243mm Width:S size = 85mmM size = 95mmL size = 105mmXL size = 115mmFinger thickness =0.05mm Palm thickness= 0.08mmMeets ASTM D5250-06 | Meets ASTM D 5250-06 |
| Physical Properties | Tensile strength = 16.3MPaElongation = 391%Meets ASTM D 5250-06 | Tensile strength =15.7MPaElongation = 385%Meets ASTM D 5250-06 | Meets ASTM D 5250-06 |
| Freedom from pinholes | Pinhole = 8/500AQL 1.5Meets ASTM D5151-06 | Pinhole = 10/500AQL 1.5Meets ASTM D5151-06 | Meets 21 CFR 800.20 |
| Powder Residual | Powder residue = 1mgMeets ASTM D5250-06 andD6124-06 | Powder residue = 1mgMeets ASTM D5250-06and D6124-06 | Meets ASTM D6124-06 |
| Cytotoxicity(ISO10993-5) | Passes | Passes | N/A |
| Biocompatibility | Primary Dermal Irritationin rabbits - under the | Primary DermalIrritation in rabbits - | Passes |
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| conditions of the study, notan irritant. | under the conditions ofthe study, not anirritant. | |
|---|---|---|
| Dermal Sensitization in theguinea pig – underconditions of the study;not a sensitizer. | Dermal Sensitization inthe guinea pig – underconditions 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.
§ 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.