(60 days)
Not Found
No
The device description and performance studies focus on the physical properties and barrier function of examination gloves, with no mention of AI or ML.
No.
The device is a glove intended to prevent contamination, not to treat a medical condition.
No
Explanation: The device is a glove intended to prevent contamination between the patient and examiner, not to diagnose a medical condition.
No
The device is a physical glove made of Poly Vinyl Chloride (PVC) and is described as a disposable device worn on the hand or finger. It is clearly a hardware medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is "worn on the examiner's hand or finger to prevent contamination between patient and examiner." This describes a barrier device used for protection during physical examination or procedures.
- Device Description: The description focuses on the physical properties of the glove as a barrier (PVC film, water tight, tensile properties).
- Lack of IVD Characteristics: An IVD device is 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.
- Performance Studies: The performance studies focus on the physical and biological properties of the glove (biocompatibility, barrier integrity) rather than analytical performance related to diagnosing or monitoring a condition.
Therefore, the description aligns with a Class I medical device used for barrier protection, not an IVD.
N/A
Intended Use / Indications for Use
Powder Free Vinyl Patient Examination Gloves, 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.
Product codes (comma separated list FDA assigned to the subject device)
LYZ
Device Description
Poly Vinyl Chloride (PVC) films form a barrier to prevent contamination between patient and examiner. The PVC rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure. The Poly (vinyl chloride) glove acts as a barrier to prevent contamination between patient and examiner. The glove is manufactured in accordance with the requirements of ASTM D5250 and ASTM D5151.
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
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)
Non-clinical tests were conducted to verify that the proposed device will meet acceptance criteria for each test. The test results demonstrated that the proposed device met the acceptance criteria found in the following standards: ISO 10993-5:2009, ISO 10993-10:2010, ASTM D5151-19, ASTM D5250-06 (Reapproved 2015), ASTM D6124-06 (Reapproved 2017).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Characteristics: Dimension (Length, Width, Thickness), Physical Properties (Tensile strength, Elongated rate), Freedom from pinholes, Powder Residual, Biocompatibility (Primary Skin Irritation, Dermal sensitization, Cytotoxicity).
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 14, 2021
Shandong Jieshi Medical Products Co.,Ltd % Chu Xiaoan Official Correspondent Beijing Easy-Link Company Rm. F302 Bldg., 41, Jing Cheng Ya Ju, Courtyard 6 of Southern Dou Ge Zhuang, Chaoyung District Beijing, 100121 China
Re: K210774
Trade/Device Name: Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LYZ Dated: February 8, 2021 Received: March 15, 2021
Dear Chu Xiaoan:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Clarence W. Murray, III, PhD DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality 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)
Device Name
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
Indications for Use (Describe)
Powder Free Vinyl Patient Examination Gloves, 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.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(K) Summary
= "The assigned 510(k) number is: K210774
Premarket Notification [510(k)] Summary
1.0 Submitter:
| Submitter's name : | Shandong Jieshi Medical Products Co.,Ltd |
|---|---|
| Submitter's address : | North Road, Fumin Avenue, Qinghe Street, |
| Caoxian County,Heze City, Shandong | |
| Province, 274400,P.R. China | |
| Phone number : | 0086-530-2061157 |
| 0086-530-2069778 | |
| Name of contact person: | Ms.Li Biao |
| Date of preparation : | 2021-02-08 |
2.0 Name of the Device
| Device Name: | Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) |
|---|---|
| Proprietary/Trade name: | Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) |
| Common Name: | Vinyl Patient Examination Glove |
| Classification Name: | Non-powdered patient examination glove |
| Device Classification: | I |
| Regulation Number: | 21 CFR 880.6250 |
| Panel: | General Hospital |
3.0 Predicate device
| Device Name: | Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) |
|---|---|
| Company name: | Zhang Jia Gang Fengyuan Plastic Product Co. Ltd. |
| 510(K) Number: | K091663 |
4.0 Device Description:
4.1 How the device functions:
Poly Vinyl Chloride (PVC) films form a barrier to prevent contamination between patient and examiner
4.2 Scientific concepts that form the basis for the device
The PVC rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure.
4
4.3 Physical and performance characteristics such as design, materials and physical properties:
The Poly (vinyl chloride) glove acts as a barrier to prevent contamination between patient and examiner. The glove is manufactured in accordance with the requirements of ASTM D5250 and ASTM D5151.
Indications for Use Statement: 5.0
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
6.0 Summary of the Technological Characteristics of the Device:
Provided below is the Technological Characteristics Comparison Table that provides a comparison between the subject device and the predicate device.
| Features & Description | Predicate Device | Subject Device | Result of Comparison | ||
|---|---|---|---|---|---|
| Company | Zhang Jia Gang | ||||
| Fengyuan Plastic | |||||
| Product Co. Ltd. | Shandong Jieshi | ||||
| Medical Products | |||||
| Co.,Ltd | -- | ||||
| 510(K) Number | K091663 | K210774 | -- | ||
| Product name | Powder Free Vinyl | ||||
| Patient Examination | |||||
| Gloves, Clear | |||||
| (non-colored) | Powder Free Vinyl | ||||
| Patient Examination | |||||
| Gloves, Clear | |||||
| (non-colored) | Similar | ||||
| Product Code | LYZ | LYZ | Same | ||
| Size | Small/ Medium/ | ||||
| Large/X large | Small/ Medium/ | ||||
| Large/X large | Same | ||||
| Intend for use | Powder Free Vinyl | ||||
| Patient Examination | |||||
| Gloves, 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. | Powder Free Vinyl | ||||
| Patient Examination | |||||
| Gloves, | |||||
| 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. | Same | ||||
| Device Description and | |||||
| Specifications | Meets ASTM | ||||
| D5250-06 | Meets ASTM | ||||
| D5250-06 | |||||
| (Reapproved 2015) | Same | ||||
| Dimensions Length | |||||
| (mm) | |||||
| ILS-2 AQL4.0 | $ ≥ $ 230mm | 231-241mm | 231-242mm | Similar | |
| Features & Description | Predicate Device | Subject Device | Result of | ||
| Comparison | |||||
| Dimensions | |||||
| Width | |||||
| (mm) | Small | 80-90 | 81-89 | 82-89 | Similar |
| Medium | 90-100 | 93-99 | 93-99 | ||
| IL S-2 | Large | 100-110 | 102-110 | 103-109 | |
| AQL4.0 | X large | 110-120 | 111-1119 | 114-119 | |
| Dimensions | |||||
| Thickness | |||||
| (mm ) | Finger | ≥0.05 | 0.05-0.10 | 0.09-0.10 | Similar |
| IL S-2 | |||||
| AQL4.0 | Palm | ≥0.08 | 0.09-0.13 | 0.10-0.11 | |
| Physical | Before aging/after aging | ||||
| Properties | Elongation ≥300% | 380-410% | 350-420% | Similar | |
| IL S-2 AQL4.0 | Tensile Strength | ||||
| ≥ 14MPa | 16-20 MPa | 15-22 MPa | |||
| Freedom from | |||||
| Pinholes | Holes at | ||||
| Inspection Level | |||||
| I AQL2.5 | Holes at | ||||
| Inspection Level I | |||||
| AQL2.5 | Holes at | ||||
| Inspection Level I | |||||
| AQL2.5 | Same | ||||
| Residual | |||||
| Powder | below 2mg of | ||||
| residual powder | 0.3mg | 0.1mg | Similar | ||
| Materials used to fabricate | |||||
| the devices | PVC | PVC | Same | ||
| Performance data | Meets | ||||
| ASTM D5151-06 | |||||
| (Reapproved 2011) | |||||
| ASTM D5250-06 | |||||
| (Reapproved 2011) | |||||
| ASTM D6124-06 | |||||
| (Reaffirmation 2011) | Meets | ||||
| ASTM D5151-19 | |||||
| ASTM D5250-06 | |||||
| (Reapproved 2015) | |||||
| ASTM D6124-06 | |||||
| (Reapproved 2017) | Same | ||||
| Single Patient Use | Single Patient Use | Single Patient Use | Same | ||
| Biocompatibility | Under the conditions | ||||
| of this study, not an | |||||
| irritant and Under the | |||||
| conditions of this | |||||
| study, not a sensitizer. | Under the conditions | ||||
| of this study, not an | |||||
| irritant and Under | |||||
| the conditions of | |||||
| this study, not a | |||||
| sensitizer. | Same | ||||
| SKIN IRRITATION | |||||
| DERMAL and | |||||
| SENSITIZATION | |||||
| STUDIES Meets ISO | |||||
| 10993-10:2002/Amd.1 | |||||
| :2006 | SKIN IRRITATION | ||||
| DERMAL and | |||||
| SENSITIZATION | |||||
| STUDIES Meets | |||||
| ISO 10993-10 Third | |||||
| Edition 2010-08-01 | |||||
| Under the conditions | |||||
| of this study, the test | |||||
| article was | |||||
| non-cytotoxicity to | |||||
| L-929 cells. | |||||
| Labeling | -Powder Free | ||||
| -Patient Examination | |||||
| Glove | |||||
| -Single Use Only |
- Manufactured For:
- Lot | -Powder Free
-Patient Examination
Glove
-Single Use Only - Manufactured For:
- Lot | Same | | |
5
Summary of Non-Clinical Performance Data: 7.0
Non-clinical tests were conducted to verify that the proposed device will meet acceptance criteria for each test. The test results demonstrated that the proposed device met the acceptance criteria found in the following standards below:
6
| ISO 10993-5:2009 | Biological Evaluation of Medical Devices - Part 5: Tests
For In Vitro Cytotoxicity |
|------------------------------------|-----------------------------------------------------------------------------------------------------|
| ISO 10993-10:2010 | Biological Evaluation of Medical Devices - Part 10: Tests
For Irritation And Skin Sensitization. |
| ASTM D5151-19 | Standard Test Method for Detection of Holes in Medical
Gloves. |
| ASTM D5250-06
(Reapproved 2015) | Standard specification for poly (vinyl chloride) gloves for
medical application. |
| ASTM D6124-06
(Reapproved 2017) | Standard Test Method for Residual Powder on Medical
Gloves |
| Characteristics | Standard |
|---|---|
| Dimension | ASTM D 5250-06(Reapproved 2015). |
| Length ≥230mm | |
| Width | |
| Small 80-90 mm | |
| Medium 90-100mm | |
| Large 100-110mm | |
| X large 110-120 mm | |
| Thickness | |
| Fingertip ≥0.05mm | |
| Palm ≥0.08mm | |
| Physical | |
| Properties | ASTM D 5250-06(Reapproved 2015). |
| Tensile strength (Before & After aging) ≥11MPa | |
| Elongated rate (Before & After aging) ≥300% | |
| Freedom from | |
| pinholes | 21 CFR 800.20 ASTM D5250-06(Reapproved 2015) ASTM D5151-19 Passed Standard Acceptance Criteria |
| Powder Residual | ASTM standard D 5250-06 (Reapproved 2015).and D6124-06(Reapproved 2017) |
| Meets |