(177 days)
The powdered vinyl patient examination glove, clear (non-colored) 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. The powder is made from cornstarch. It is color free and is sold as non sterile.
Powdered vinyl patient examination gloves, clear (non-colored) are made of polyvinyl chloride, and are non sterile that meets all of the requirements of ASTM standard D 5250-06, except for sterility requirements. The powder is made from cornstarch. The gloves are color free.
The provided text describes the performance of "Powdered Vinyl Patient Examination Gloves, Clear (non-colored)" (or other clients private labeling) to demonstrate substantial equivalence to predicate devices, rather than a device that employs AI or requires complex studies. Therefore, many of the requested categories (e.g., sample size for test/training sets, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, type of ground truth for training) are not applicable to this type of device submission.
The acceptance criteria and device performance are based on meeting established consensus standards for patient examination gloves.
1. Table of Acceptance Criteria and Reported Device Performance
| Description | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Dimension | Meets ASTM D5250-06 | Meets ASTM D5250-06 |
| Physical Property | Meets ASTM D5250-06 | Meets ASTM D5250-06 |
| Free of Pinhole | Meets ASTM D5151-06 | Meets ASTM D5151-06 |
| Residue Powder | Meets ASTM D6124-06 (< 10 mg/dm²) | Meets ASTM D6124-06 (< 10 mg/dm²) |
| Primary Skin Irritation | No skin irritation (ISO 10993-10) | No skin irritation |
| Dermal Sensitization | No dermal sensitization (ISO 10993-10) | No dermal sensitization |
Study Proving Acceptance Criteria:
The study proving the device meets the acceptance criteria consisted of non-clinical tests conducted following the recommended procedures outlined in the respective consensus standards. The summary explicitly states: "Tests were conducted following the recommended procedures outlined in the respective consensus standards, and results for powdered Vinyl Patient Examination Gloves, Clear (non-colored) (or other clients private labeling), manufactured by "Wealth On (Jiangsu) Gloves Co., Ltd" met all relevant requirements in the test standards, and are comparable to the predicate device."
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided text. For medical devices like examination gloves, testing a statistically representative sample size according to the relevant ASTM or ISO standards is implied.
- Data Provenance: The tests were conducted by the manufacturer, Wealth On (Jiangsu) Co., Ltd, located in Jiangsu Province, China. The data would therefore be prospective from the manufacturer's testing process.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable as the "ground truth" for this device is determined by objective, standardized physical and biocompatibility tests (e.g., measuring dimensions, tensile strength, freedom from pinholes, or observing skin reactions) as defined by the ASTM and ISO standards, not by expert consensus on interpretation.
4. Adjudication method for the test set:
Not applicable. Performance is determined by objective technical measurements against defined standard thresholds, not by human adjudication of ambiguous findings.
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 not an AI-assisted device, nor does it involve human readers or diagnostic interpretation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used:
The ground truth is based on established consensus standards (ASTM D5250-06, ASTM D5151-06, ASTM D6124-06, and ISO 10993-10) which define the physical, performance, and biocompatibility requirements for patient examination gloves.
8. The sample size for the training set:
Not applicable. This device does not have a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established:
Not applicable. This device does not have a "training set" or a ground truth established for it in that manner. The "ground truth" for its performance is determined by adherence to the aforementioned objective industry standards.
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JAN 3 1 2013
Section 5: 510(k) Summary:
This summary of 510k safety and effectiveness information is being submitted In accordance with the requirements of 21CFR 807.92
Submitter & Foreign Manufacture Identification
Wealth On (Jiangsu) Co., Ltd Dongyuan Village, Hengji Town, Jianhu County Yancheng, Jiangsu Province, China Tel: 86- 21-33517339 Submitter's FDA Registration Number: 3009307502
US Agent and Contact Person
Charles Shen Manton Business and Technology Services 5 Carey Street Pennington, NJ 08534 Tel: 608-217-9358 Email: cyshen@aol.com
Date of Summary: June, 2012
Device Name: Proprietary Name:
Common Name: Classification Name: Device Classification: Regulation Number: Panel: General Product Code:
Powdered Vinyl Patient Examination Glove, Clear (noncolored) (or other clients private labeling) Patient examination glove Patient examination glove I 21 CFR 880.6250 Hospital LYZ
Predicate Device Information:
- (1) K081657, "Powdered Vinyl Patient Examination Gloves, Light Yellow", manufactured by "Jiangsu Cureguard Glove Co., Ltd. "
- (2) K110219, "Powder Free Vinyl Patient Examination Gloves", manufactured by "Wealth on (Jiangsu) Co., Ltd. (our own company). "
Device description:
Powdered vinyl patient examination gloves, clear (non-colored) are made of polyvinyl chloride, and are non sterile that meets all of the requirements of ASTM standard D
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5250-06, except for sterility requirements. The powder is made from cornstarch. The gloves are color free.
Indications for Use:
The powdered vinyl patient examination glove, clear (non-colored), 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. The powder is made from cornstarch. It is color free and is sold as non sterile.
Comparison to Predicate Devices
The powdered vinyl patient examination gloves, clear (non-colored), non sterile are compared with the following Predicate Devices in terms of in terms of these three areas: Indications for Use/Design/Material, Performance, and Labeling.
- (1) K081657, "Powdered Vinyl Patient Examination Gloves, Light Yellow", manufactured by "Jiangsu Cureguard Glove Co., Ltd."
- (2) K110219, "Powder Free Vinyl Patient Examination Gloves", manufactured by "Wealth on (Jiangsu) Co., Ltd. (our own company)." ·
Substantial equivalence is established with respect to intended use, Labeling, performance, design, materials, and other applicable characteristics. Side-by-side comparison tables that include the following four areas are provided below:
- Indication for Use A:
- Labeling (labels, instructions for use, promotional material) for the legally B: marketed device to which substantial equivalence is claimed.
- Performance data supporting substantial equivalence C:
- Design and materials D:
- Indications for Use: A:
The following table shows similarities and differences in indications for use between our device and the predicate devices.
| Description | Our Device | Predicate Device 1 (K081657) | Predicate Device 2 (K110219) |
|---|---|---|---|
| Indicationfor Use | Disposable device intended formedical purposes that is worn onthe examiner's hand or finger toprevent contamination betweenpatient and examiner. The powderis made from cornstarch. | Disposable device intended formedical purposes that is wornon the examiner's hand orfinger to prevent contaminationbetween patient and examiner. | Disposable device intended formedical purposes that is worn onthe examiner's hand or finger toprevent contamination betweenpatient and examiner. The powderis Powder free |
Table 5.1: Comparison of Indications for Use
Our device and K081657, K110219 are almost identical in terms of indications for use. The only difference is that our device uses cornstarch as the powder source, while the
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powder source for K081657 is not specified. This minor difference is not significant enough to alter how and when the gloves should be used.
Our device and K110219 are also almost identical in terms of indications for use. The only difference is that K110219 is powder free while this device is powdered with cornstarch as the powder source. This minor difference is not significant enough to alter how and when the gloves should be used.
B: Labeling:
The labels for both our device and predicate device are provided in Section 13 of this submission (Sec13.1 and 13.2 for our device, Sec13.3 for the predicate device K081657, and Sec 11.4 for K110219).
The following table shows similarities and differences of key elements of the labeling between our device and the predicate devices.
| Description | Our Device | Predicate Device 1(K081657) | Predicate Device 2(K110219) |
|---|---|---|---|
| Product Name | Yes (Powered VinylExamination Gloves) | Yes (Cureguard GlovesVinyl Powdered) | Yes (Power Free VinylExamination Gloves) |
| Manufacturer Nameand Address | Yes | No | Yes |
| Product Model,Size, and LotNumber | Yes | Yes | Yes |
| Quantity/Box | Yes | Yes | Yes |
| Color Statement | Yes | Yes | Yes |
| StorageRecommendation | Yes | No | Yes |
| Single UseStatement | Yes | Yes | Yes |
| Sterility Statement | Yes | Yes | Yes |
Table 5.2: Comparison of Key Elements in Labeling
The label for this device under submission is identical to K110219, except for this device is labeled as Powdered, while K110219 is labeled as powder free.
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The label for this device under submission is very similar to K081657. Actually it contains all the information the K081657 label has, and more.
C: Performance:
The following table shows similarities and differences of the performance between our device and the predicate devices. Tests were conducted following the recommended procedures outlined in the respective consensus standards, and results for powdered Vinyl Patient Examination Gloves, Clear (non-colored) (or other clients private labeling), manufactured by "Wealth On (Jiangsu) Gloves Co., Ltd" met all relevant requirements in the test standards, and are comparable to the predicate device.
Table 5.3: Comparison of Physical, Biocompatibility and Performance Testing
| Description | Our Device | Predicate Device 1(K081657) | Predicate Device 2(K110219) |
|---|---|---|---|
| Dimension | Meets ASTM D5250-06 | Meets ASTM D5250-06 | Meets ASTM D5250-06 |
| Physical Property | Meets ASTM D5250-06 | Meets ASTM D5250-06 | Meets ASTM D5250-06 |
| Free of Pinhole | Meets ASTM D5151-06 | Meets ASTM D5151-06 | Meets ASTM D5151-06 |
| Residue Powder | Meets ASTM D6124-06< 10 mg/dm² | Meets ASTM D6124-06< 10 mg/dm² | No Powder, Meets ASTM D6124-06. < 2 mg/glove |
| Primary SkinIrritation(ISO 10993-10) | No skin irritation | No skin irritation | No skin irritation |
| Dermalsensitization (ISO10993-10) | No dermal sensitization | No dermal sensitization | No dermal sensitization |
More details of non-clinical tests are summarized in Sections 15 & 18.
Our device and K081657 both meet dimensional, physical, and performance requirements set forth in ASTM D5250-06, and the biocompatibility requirements.
Our device and K110219 also both meet dimensional, physical, and performance requirements set forth in ASTM D5250-06, and the biocompatibility requirements. The only difference is that this device under submission is powdered with amount < 10 mg/dm', while K110219 is powder free, with amount < 2 mg/glove.
In conclusion, the powdered vinyl patient examination gloves, clear (non-colored), non sterile, manufactured by "Wealth On (Jiangsu) Gloves Co., Ltd." meet requirements per ASTM D5250-06, ASTM D6124-06, ASTM D 5151-06, and ISO 10993-10. It is safe and
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effective, and its performance meets the acceptance criteria pre-defined in the test standards and its intended uses. The test results are also comparable to the predicate device.
D: Design and Material
The following table shows similarities and differences in design and material between our device and the predicate devices.
| Description | Our Device | Predicate Device 1(K081657) | Predicate Device 2(K110219) |
|---|---|---|---|
| Basic Design | A garment covering the hand andwaist area. Gloves have separatesheaths or openings for each fingerand the thumb. | Same | Same |
| Materials | Poly Vinyl Chloride | Same | Same |
| Powder | Yes/ Cornstarch | Yes/ Information on typesof powder not available | No |
| Size | XS, S, M, L, XL | Information not available | XS, S, M, L, XL |
| Single Use | Yes | Yes | Yes |
| Color | Colorless | Light Yellow | Colorless |
| Sterile | Non sterile | Non sterile | Non sterile |
Table 5.4: Comparison of Indications for Use, Design, and Material
Our device and K081657 share the similar basic design and uses the same material. The only difference is that our device is color free while the predicate device has light yellow color. Free of pigment makes our device safer and more biocompatible.
Our device and K110219 also share the similar basic design and uses the same material. The only difference is that this device is powdered while K110219 is powder free. Cornstarch is used as the source of powder which has long been established as safe and biocompatible.
A brief discussion of the non-clinical testing data that was submitted, referenced or relied on to demonstrate that the Subject Device is safe and effective, and whose performance meets the requirements of its user-defined acceptance criteria and intended uses:
Powdered vinyl patient examination glove meet requirements per ASTM D5250-06, ASTM D6124-06, ASTM D 5151-06, and ISO 10993-10. It is safe and effective, and its performance meets the requirements of its pre-defined acceptance criteria and intended uses.
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A brief discussion of the clinical submitted, reference, or relied on in the premarket notification submission for a determination of substantial equivalence.
Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.
Substantial Equivalent Conclusions
Based on the comparison of intended use, design, materials, and performance, our powdered patient vinyl examination gloves, clear (non-colored) are substantial equivalent to its predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the symbol. The caduceus is depicted with three intertwined strands and a stylized bird-like shape at the top. The text is in all caps and is arranged to follow the curve of the circle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 31, 2013
Wealth On (Jiangsu) Company, Limited C/O Mr. Charles Shen Manton Business and Technology Services 5 Carey Street PENNINGTON NJ 08534
Re: K122396
Trade/Device Name: Powdered Vinyl Patient Examination Gloves, Clear (non-colored) (or other clients private labeling) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: December 30, 2012 Received: January 8, 2013
Dear Mr. Shen:
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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Page 2 - Mr. Shen
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 (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/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/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 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.
Nor
Anthony D. Watson, B.S., M.S., M.B.A. 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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Indications for Use Section 4:
510(k) Number (if known): K122396
Device Name: Powdered Vinyl Patient Examination Gloves, Clear (non-colored) (or other clients private labeling)
Indications for Use:
The powdered vinyl patient examination glove, clear (non-colored) 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. The powder is made from cornstarch. It is color free and is sold as non sterile.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sheila A. Murphey
Digitally signed by Sheila A. Murphey
DN: c=US, o=U.S. Government, ou=HHS,
ou=FDA, ou=People, cn=Sheila A. Murphey,
0.9.2342.19200300.100.1.1=1300369048
Date: 2013.01.28 13:46:56 -05'00'
| (Division Sign-Off) |
|---|
| Division of Anesthesiology, General Hospital |
| Infection Control, Dental Devices |
| 510(k) Number: | K122396 |
|---|---|
| ---------------- | --------- |
Section 4: Indication for Use
Page 1 of 1
§ 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.