(208 days)
Not Found
No
The device description and performance studies focus on the physical properties and biocompatibility of a patient examination glove, with no mention of AI or ML.
No.
This device, a patient examination glove, is intended to prevent contamination and is classified as Class I, indicating a low risk and generally not a therapeutic device. It does not actively treat or diagnose a disease.
No
Explanation: The document clearly states that the device is a "patient examination glove" intended to prevent contamination. There is no mention of it being used to diagnose conditions or providing diagnostic information.
No
The device description and performance studies clearly indicate this is a physical medical device (patient examination glove) and not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is a "patient examination glove" worn on the hand to prevent contamination between healthcare personnel and the patient's body fluids, waste, or environment. This is a barrier device for physical protection.
- Device Description: It's classified as a Class I device under 21 CFR 880.6250, which is for "Patient Examination Glove." This classification is for general and plastic surgery devices, not IVDs.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Detecting or measuring substances in the body
- Using reagents or assays
The device's function is purely a physical barrier. It does not perform any diagnostic testing or analysis of biological samples.
N/A
Intended Use / Indications for Use
A patient examination glove is a disposable device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body. fluids, waste or environment.
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880.6250)
Product codes
LYZ
Device Description
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirement of ASTM Standard D5250-06.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands or finger
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare and similar personnel
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 standards used for Weilin Plastic and Rubber Products Co., Ltd. glove production are based on ASTM-D-5250-06. All testing meets requirements for Physical and Dimensions Testing conducted on gloves, Inspection Level S-2, AQL 2.5.
The FDA 1000 ml. Water Fill Test was also conducted with samplings of AOL 2.5, Inspection Level I, meeting these requirements, Primary Skin irritation and Skin Sensitization (allergic contact dermatitis) testing was conducted with results showing no primary skin irritant or sensitization reactions.
There are no special labeling claims and we do not claim our gloves as hypoallergenic is conducted to insure that our gloves meet our "powder-free" claims (contain no more than 2 mg powder per glove).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510 (K) SUMMARY
JUN 1 7 2013
This summary of 510(K) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21CFR 807.92.
Submitter's Identification: 1.
Weilin Plastic and Rubber Products Co., Ltd. 601 Jiangjunsan Road Qingzhou, Shandong, China
Date summary prepared: Nov 03, 2012
2. Name of the Device:
Weilin Plastic and Rubber Products Co., Ltd. . Vinyl Examination Powder Free Gloves; Clear; Size Large
· 3. Predicate Device Information:
Shiiiazhuang Hongxiang Plastic Products Ltd. Synthetic Vinyl Patient Examination Gloves - Powder Free (K992821)
4. Device Description:
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirement of ASTM Standard D5250-06.
5. Intended Use:
A patient examination glove is a disposable device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body. fluids, waste or environment.
6. Comparison to Predicate Devices:
Weilin Plastic and Rubber Products Co., Ltd. Vinyl Examination Powder Free Gloves, clear, are substantially equivalent in safety and effectiveness to the Shijiazhuang Hongxiang Plastic Products Co., Ltd.(K992821). See Table 7-2.
1
Discussion of Non-Clinical tests performed for Determination of 7. Substantial Equivalence are as follows:
The standards used for Weilin Plastic and Rubber Products Co., Ltd. glove production are based on ASTM-D-5250-06. All testing meets requirements for Physical and Dimensions Testing conducted on gloves, Inspection Level S-2, AQL 2.5.
The FDA 1000 ml. Water Fill Test was also conducted with samplings of AOL 2.5, Inspection Level I, meeting these requirements, Primary Skin irritation and Skin Sensitization (allergic contact dermatitis) testing was conducted with results showing no primary skin irritant or sensitization reactions.
There are no special labeling claims and we do not claim our gloves as hypoallergenic is conducted to insure that our gloves meet our "powder-free" claims (contain no more than 2 mg powder per glove).
8. Discussion of Clinical Tests Performed:
Not Applicable - There is no hypoallergenic claim.
9. Conclusions:
Weilin Plastic and Rubber Products Co., Ltd. Vinyl Examination Powder Free Gloves, clear, conform fully to ASTM-D-5250-06 standard as well as applicable 21 CFR references, and, meets pinhole FDA requirements, biocompatibility requirements and labeling claims as shown by data in Section 7. There are no safety/efficacy issues or new claims from the "substantial equivalence" products cited.
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| Proposed Device | Predicate Device (K992821) | |
|---|---|---|
| Description | Weilin Plastic and Rubber Products Co., Ltd | |
| Powder-Free Vinyl Patient Examination | ||
| Gloves, Clear | Shijiazhuang Hongxiang Powder-free | |
| Vinyl Patient Examination Gloves | ||
| Labeling: Instruction | ||
| for use | A garment covering the hand and waist area. | |
| Clovers have separate sheaths or openings for | ||
| each finger and the thumb. | Substantially equivalent | |
| Labeling: Labels on | ||
| the carton | Labels include: Product name; color; "single | |
| use Only" size, piece count, lot number, | ||
| distributor name, and manufacturer address. | Substantially equivalent | |
| Device Materials | Poly Vinyl Chloride | |
| Polyurethane | ||
| Diisononyl Phthalate (DINP) | Substantially equivalent | |
| Before Aging: Tensile | ||
| Strength(Mpa) and | ||
| Ultimate Elongations | Average Tensile Strength (Mpa): 16.9 | |
| Average Ultimate Elongations: 550% | Substantially equivalent | |
| After Aging: Tensile | ||
| Strength(Mpa) and | ||
| Ultimate Elongations | Average Tensile Strength (Mpa): 14.4 | |
| Average Ultimate Elongations: 500% | Substantially equivalent | |
| Overall Length on | ||
| Medium Size | Average over 230mm | Substantially equivalent |
| Width of Palm on | ||
| Medium Size | Average 95mm | Substantially equivalent |
| Palm Thickness | Average 0.073 mm | Substantially equivalent |
| Figure Thickness | Average 0.090 mm | Substantially equivalent |
| Residual Powder | According to ASTM D6124-06 Standard Test | |
| Method for Residual Powder on Medical gloves | ||
| for the determination of residual powder | ||
| content. Testing result indicates the weight of | ||
| all types of residual or powder on finished | ||
| powder-free gloves as Trade/Device Name: Vinyl Examination Powder Free Gloves, Clear Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: March 22, 2013 Received: May 16, 2013 |
Dear Mr. Zhu:
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 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 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.
Image /page/4/Picture/5 description: The image is a close-up of a white surface. The surface appears to be blank and featureless. The lighting is even, and there are no shadows or highlights visible. The image is simple and minimalist in composition.
-Sincerely-yours,-
Tejas
Clinic
DAGI
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRIO
FOR
Kwame Ulmer M.S Acting Division Director Division of Anesthesiology, General Hospital Respiratory, Infection Control and Dental Device Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/5/Picture/0 description: The image shows a black and white drawing of a hand with fingers spread apart. The hand is positioned inside of a square frame. The hand appears to be reaching out or waving. The image is simple and lacks any background details.
Weilin Plastic and Rubber Products Co., Ltd.
601 Jiangjunsan Road Qingzhou, Shandong, China
INDICATIONS FOR USE
Applicant: Weilin Plastic and Rubber Products Co., Ltd.
510(k) Number:
Vinyl Examination Powder Free Gloves, Clear Device Name:
Indications of Use:
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880.6250)
Prescription Use
Over the Counter Use _________________________________________________________________________________________________________________________________________________________ X
Factory Initials
Elaine S. Mayha
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number; K123590