(84 days)
Not Found
No
The device is a disposable examination glove, and the summary describes standard physical and biological testing, with no mention of AI or ML.
No.
The device is a patient examination glove, intended to prevent contamination, not to treat a medical condition or ailment.
No
The device is a patient examination glove, intended to prevent contamination between patient and examiner, not to diagnose a condition.
No
The device description clearly states it is a physical product (gloves) and does not mention any software components.
No, 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 or finger to prevent contamination between patient and examiner. This is a barrier device for physical protection.
- Device Description: It's a glove, a physical barrier.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This glove does not interact with or analyze such specimens.
- Regulatory Standards: The standards mentioned (ASTM D5250, D6124, D5151, ISO 10993-10) are related to the physical properties, safety, and performance of examination gloves, not diagnostic tests.
This device is a medical device, specifically a patient examination glove, but it falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The powder free 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. It is sold as non sterile.
Product codes (comma separated list FDA assigned to the subject device)
LYZ
Device Description
Powder free vinyl patient examination gloves, clear (non-colored), non sterile that meets all of the requirements 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
hand or finger
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner / 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)
Tests were conducted following the recommended procedures outlined in the respective consensus standards, and results for Powder Free Vinyl Patient Examination Gloves (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.
Powder free vinyl patient examination gloves 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.
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.
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
§ 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.
0
Section 5: 510k Summary
APR 1 9 2011
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: N/A
US Agent and Contact Person
Chengyu Shen Manton Business and Technology Services 5 Carey Street Pennington, NJ 08534 Tel: 608-217-9358 Email: cyshen@aol.com
Date of Summary: July 22, 2010
| Device Name: | Powder Free Vinyl Patient Examination Gloves |
|---|---|
| Proprietary Name: | Powder Free Vinyl Patient Examination Gloves (or other |
| clients private labeling) | |
| Common Name: | Patient examination glove |
| Classification Name: | Patient examination glove |
| Device Classification: | I |
| Regulation Number: | 21 CFR 880.6250 |
| Panel: General | Hospital |
| Product Code: | LYZ |
Predicate Device Information:
- (1) K100699, "Powder Free Vinyl Patient Examination Gloves, Clear(noncolored)", manufactured by "Shijiazhuang Star Plastic Co., Ltd"
Device description:
Powder free vinyl patient examination gloves, clear (non-colored), non sterile that meets all of the requirements of ASTM standard D 5250-06, except for sterility requirements.
1
K110219
Section 5: 510k Summary
Intended Use:
The powder free 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. It is sold as non sterile.
Comparison to Predicate Devices
The powder free vinyl patient examination gloves, non sterile are compared with the following Predicate Devices in terms of intended use, design, material, specifications, and performance.
- (1) K100699, "Powder Free Vinyl Patient Examination Gloves, Clear(noncolored)", manufactured by "Shijiazhuang Star Plastic Co., Ltd"
The following table shows similarities and differences of use, design, and material between our device and the predicate devices.
| Description | Our Device | Predicate Device (K100699) |
|---|---|---|
| Indication for | ||
| Use | Disposable device intended for medical | |
| purposes that is worn on the examiner's hand | ||
| or finger to prevent contamination between | ||
| patient and examiner. | Same | |
| Basic Design | A garment covering the hand and waist area. | |
| Gloves have separate sheaths or openings for | ||
| each finger and the thumb. | Same | |
| Materials | Poly Vinyl Chloride | Same |
| Size | XS, S, M, L, XL | Information unavailable |
| Single Use | Yes | Yes |
| Sterile | Non sterile | Non sterile |
Table 5.1: Comparison of Intended Use, Design, and Material
2
Section 5: 510k Summary
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 Powder Free Vinyl Patient Examination Gloves (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.
| Description | Our Device | Predicate Device (K100699) |
|---|---|---|
| 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 21 CFR 800.20 |
| Residue Powder | Meets ASTM D6124-06 | Meets ASTM D6124-06 |
| Primary Skin | ||
| Irritation | ||
| (ISO 10993-10) | Passes | Passes |
| Dermal sensitization | ||
| (ISO 10993-10) | Passes | Passes |
Table 5.2: Comparison of Physical, Biocompatibility and Performance Testing
More details of non-clinical tests are summarized in Sections 15 & 18.
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:
Powder free vinyl patient examination gloves 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.
3
Section 5: 510k Summary
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 vinyl disposable examination gloves powder free are substantial equivalent to its predicate devices.
4
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
APR 1 9 2011
Wealth On (Jiangsu) Company, Limited C/O Mr. Chengyu Shen Official Correspondent Manton Business and Technology Services 5 Carev Street Pennington, New Jersey 08534
Re: K110219
Trade/Device Name: Powder Free Vinyl Patient Examination Gloves (or other Clients Private Labeling) Regulation Number: . 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: March 28, 2011 Received: March 29, 2011
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.
5
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/CDRH/CDRHOffices/ ucm 1 15809.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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
for
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
6
Section 4: Indication for Use
Indications for Use Section 4:
510(k) Number (if known): N/A Device Name: Powder Free Vinyl Patient Examination Gloves (or other clients private labeling)
Indications for Use:
The powder free 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. It 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)
Edith H. F. Clamie-Williams
(Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
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