(17 days)
Not Found
No
The device description and performance studies focus on the physical properties and biocompatibility of examination gloves, with no mention of AI or ML.
No
The device is described as an examination glove intended to prevent contamination, not to provide therapy.
No
The device is a glove for preventing contamination, not for diagnosing medical conditions.
No
The device description clearly states it is a physical glove made of Poly (vinyl chloride) compound, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as being worn on the hand or finger to prevent contamination between patient and examiner. This is a barrier function, not a diagnostic test performed on a sample from the body.
- Device Description: The description focuses on the material, physical properties, and standards related to examination gloves. There is no mention of reagents, assays, or any components used to analyze biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a sample (blood, urine, tissue, etc.)
- Detecting or measuring a substance in a sample
- Providing information for diagnosis, monitoring, or screening of a disease or condition
- Classification: The device is classified under 21 CFR 880.6250, which is the regulation for Patient Examination Gloves. This regulation is for medical devices, but not specifically for IVDs.
In summary, the device is a medical device used for barrier protection, not for performing diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
Disposable Vinyl Examination Gloves 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
The subject device is a patient examination glove made of Poly (vinyl chloride) compound. It is Non-Sterile, Powder free and is clear in colour. The device is ambidextrous and can be worn on either the left or right hand. (Per 21 CFR 880.6250, class I). The device provides four specifications: S, M, L and XL. The device meets all the specifications in ASTM D5250-19, Standard specification for Vinyl Examination Gloves. Additionally, the gloves have been tested for biocompatibility per ISO 10993-10, ISO 10993-23, ISO 10993-5
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)
Non-Clinical Testing:
Biocompatibility Testing:
- ISO 10993-10: Skin Sensitization test
- ISO 10993-23:Skin Irritation test
- ISO 10993-5: In vitro cytotoxicity test
Performance Testing:
- ASTM D5250-19 Standard Specification for Poly (vinyl chloride) Gloves for Medical Application
- ASTM D6124-06 (Reapproved 2017) Standard Test Method for Residual Powder on Medical Gloves
- ASTM D5151-19 Standard Test Method for Detection of Holes in Medical Gloves
Key Results:
- Dimensions (length, width, thickness): Pass (Length: 240 mm min, Width: S: 89-90mm, M: 99 mm, L:105-106 mm, XL:119-120 mm, Thickness: Palm – 0.080mm Min, Finger–0.080mm Min)
- Physical properties (Tensile Strength, Elongation) Before Aging: Pass (Tensile Strength: 16.0MPa, min, Elongation: 304%, min.)
- Physical properties (Tensile Strength, Elongation) After Aging: Pass (Tensile Strength:16.7MPa, min, Elongation: 301%, min.)
- Freedom from Holes: Pass (No leakage, 80 of 80 passed)
- Residual Powder: Pass (average 0.1 mg per glove)
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
Image /page/0/Picture/0 description: The image contains 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 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 20, 2024
Anqing Pukang Medical Technology Co., LTD. % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114
Re: K241252
Trade/Device Name: Disposable Vinyl Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-powdered patient examination glove Regulatory Class: Class I, reserved Product Code: LYZ Dated: May 3, 2024 Received: May 3, 2024
Dear Prithul Bom:
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 (the 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 available 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
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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).
2
Sincerely,
Allan Guan -S
For Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K241252
Device Name Disposable Vinyl Examination Gloves
Indications for Use (Describe)
Disposable Vinyl Examination Gloves 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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510(K) Summary
This summary of 510(k) is being submitted in accordance with 21 CFR 807.92. Date prepared: May 20, 2024 A. Applicant:
Name: Anqing Pukang Medical Technology Co., LTD. Address: No 7 Haian Road, Anqing City, Anhui,China. Contact: Ms. Min Gao Title: QE Tel: +86-18266365220 Email: 474112523@qq.com
Submission Correspondent: Primary contact: Max Li Anqing Pukang Medical Technology Co., LTD. No 7 Haian Road, Anqing City, Anhui,China. Tel: +86-536-6136888 Email: maxli@basicmedical.com
B. Device:
Trade Name: Disposable Vinyl Examination Gloves Common Name: Non-Powdered Patient Examination Glove
Regulatory Information Classification Name: Vinyl Patient Examination Glove Classification: Class I Product code: LYZ Regulation Number: 21 CFR 880.6250 Review Panel: General Hospital and Personal Use
C. Predicate device:
K223008 Name of the device: Disposable Vinyl Examination Gloves Owner's Name: JIANGXI HANDSPRO PRODUCTS SOLUTIONS CO., LTD.
D. Indications for use of the device:
Disposable Vinyl Examination Gloves is a disposable device intended for medical purposes that is worn on the examiners' hand or finger to prevent contamination between patient and examiner.
Device Description: نن
The subject device is a patient examination glove made of Poly (vinyl chloride) compound. It is Non-Sterile, Powder free and is clear in colour. The device is ambidextrous and can be worn on either the left or right hand. (Per 21 CFR 880.6250, class I). The device provides four specifications: S, M, L and XL. The device meets all the
5
specifications in ASTM D5250-19, Standard specification for Vinyl Examination Gloves. Additionally, the gloves have been tested for biocompatibility per ISO 10993-10, ISO 10993-23, ISO 10993-5
F. Summary of Technological Characteristics
Disposable Vinyl Examination Gloves are compared with the predicate device in terms of intended use, design, material, specifications, and performance.
The following table shows similarities and differences of use, design, and material between the proposed device and the predicate device.
| Device | Proposed Device | Predicate Device | Result |
|---|---|---|---|
| 510K # | K241252 | K223008 | - |
| Product Name | Disposable Vinyl Examination Gloves | Disposable Vinyl Examination Gloves | - |
| Product Code | LYZ | LYZ | Same |
| Regulation Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Indications for use | Disposable Vinyl Examination Gloves 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. | Disposable Vinyl Examination Gloves 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 |
| Powder free | Yes | Yes | Same |
| Design feature | Ambidextrous. | Ambidextrous. | Same |
| Material | Vinyl | Vinyl | Same |
| Color | Clear | Clear | Same |
| Size | S, M, L, XL | S, M, L, XL | Same |
| Sterile | Non-Sterile | Non-Sterile | Same |
| Use | Singe use | Single use | Same |
Table 1 General Comparison of Proposed and Predicate Devices
Table 2 Comparison of Physical, Biocompatibility and Performance Testing
| CHARACTERSTICS | STANDARDS | DEVICE PERFORMANCE | Remarks | ||
|---|---|---|---|---|---|
| SUBJECT | PREDICATE | ||||
| Name of device | Disposable Vinyl | ||||
| Examination Gloves | Disposable Vinyl | ||||
| Examination Gloves | --- | ||||
| Dimensions | ASTMD5250- 19 | Length: | |||
| S/M/L/XL: ≥230; | Length: | ||||
| S/M/L/XL: ≥230; | Same | ||||
| Physical Properties | ASTMD5250- 19 | Width: | Width: | Same | |
| S: 85±5 | |||||
| M: 95±5 | |||||
| L: 105±5 | |||||
| XL: 115±5 | S: 85±5 | ||||
| M: 95±5 | |||||
| L: 105±5 | |||||
| XL: 115±5 | |||||
| Thickness: | |||||
| Palm: ≥0.08 | |||||
| Finger: ≥0.08 | Thickness: | ||||
| Palm: ≥0.08 | |||||
| Finger: ≥0.08 | |||||
| Before Aging | |||||
| Tensile Strength | |||||
| min 11 Mpa | |||||
| Ultimate Elongation | |||||
| Min 300% | Before Aging | ||||
| Tensile Strength | |||||
| min 11 Mpa | |||||
| Ultimate Elongation | |||||
| Min 300% | |||||
| After Aging | |||||
| Tensile Strength | |||||
| min 11 Mpa | |||||
| Ultimate Elongation | |||||
| Min 300% | After Aging | ||||
| Tensile Strength | |||||
| min 11 Mpa | |||||
| Ultimate Elongation | |||||
| Min 300% | |||||
| Powder Free | ASTMD5250- 19 | ≤2 mg/glove | ≤2 mg/glove | Same | |
| Freedom from Holes | ASTM D5250- 19 | ||||
| ASTM D5151- 19 | Complies with | ||||
| ASTM D5250- 19 | |||||
| and ASTM D5151- 19 G- | |||||
| 1, AQL 2.5 | Complies with | ||||
| ASTM D5250- 19 | |||||
| and ASTM D5151- 19 G- | |||||
| 1, AQL 2.5 | Same | ||||
| Biocompatibility | Primary Skin | ||||
| Irritation- | |||||
| ISO 10993- | |||||
| 23:2021; | Under the conditions of this | ||||
| study, the polar and | |||||
| nonpolar extracts of the test | |||||
| article did not induce skin | |||||
| irritation. | Under the conditions of | ||||
| the study, not an irritant | Similar① | ||||
| Dermal | |||||
| Sensitization- | |||||
| ISO 10993- | |||||
| 10:2010 | Under the conditions of | ||||
| this test, the polar and | |||||
| non-polar extracts of the | |||||
| test article did not cause | |||||
| skin sensitization | |||||
| reaction. | Under the conditions of | ||||
| the study, not a sensitizer | Same | ||||
| In vitro | |||||
| cytotoxicity | |||||
| ISO10993- | |||||
| 5:2009 | Under the conditions of | ||||
| this study, the extract of | |||||
| the test article did not | |||||
| show potential toxicity to | |||||
| L-929 cells. | Under conditions of the | ||||
| study, did not show | |||||
| potential toxicity to L- | |||||
| 929 cells. Complies with | Same |
6
7
(1) The new version of standard for Skin Irritation we refer is ISO 10993-23:2021, the test method and process is the same as the old version ISO 10993-10
Analysis: The proposed device has the Skin Sensitization test, Primary Skin Irritation test and the In vitro cytotoxicity test, the same as the predicate device.
G. Summary of Non-Clinical Testing
A Biocompatibility
Biocompatibility Testing according to ISO 10993-1:2018, the nature of body contact for the subject device is Surface Device category, Skin Contact and duration of contact is A-Limited (≤24h). The following tests for the subject device were conducted to evaluated the biocompatibility of Disposable Vinyl Examination Gloves:
- ISO 10993-10: Skin Sensitization test
- ISO 10993-23:Skin Irritation test
- · ISO 10993-5: In vitro cytotoxicity test
A Performance Testing
Physical performance testing of the proposed device was conducted as per ASTM D5250-19 Standard Specification for Poly (vinyl chloride) Examination Gloves.
To summarize, the performance testing of the subject device was conducted to adequately demonstrate the effectiveness of the device in accordance with the relevant test methods cited below:
- ASTM D5250-19 Standard Specification for Poly (vinyl chloride) Gloves for Medical Application
- ASTM D6124-06 (Reapproved 2017) Standard Test Method for Residual Powder on Medical Gloves
- ASTM D5151-19 Standard Test Method for Detection of Holes in Medical Gloves
| Test Method | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| Dimensions | |||
| (length) | |||
| (width) | |||
| (thickness) | The purpose of the | ||
| test is to evaluate the | |||
| physical dimension of | |||
| the glove | Length | ||
| 230 mm min | Pass | ||
| 240 mm min | |||
| Width(mm) | Pass | ||
| S: $85\pm5$ | |||
| M: $95\pm5$ | |||
| L: $105\pm5$ | |||
| XL: $115\pm5$ | S: 89-90mm | ||
| M: 99 mm | |||
| L:105-106 mm | |||
| XL:119-120 mm | |||
| Thickness(mm): | |||
| Palm: Min 0.08 | |||
| Finger: Min 0.08 | Pass | ||
| Palm – 0.080mm Min | |||
| Finger–0.080mm Min | |||
| Physical | |||
| properties | The purpose of the | ||
| test is to evaluate the | |||
| tensile strength and | |||
| ultimate elongation | |||
| before and after | |||
| aging | Before Aging: | ||
| Tensile Strength: 11 MPa, min. | |||
| Elongation: 300%, min. | Pass | ||
| Before Aging: | |||
| Tensile Strength: 16.0MPa, min. | |||
| Elongation: 304%, min. | |||
| After Aging: | |||
| Tensile Strength: 11 MPa, min. | |||
| Elongation:300%, min. | After Aging: | ||
| Tensile Strength:16.7MPa, min. | |||
| Elongation: 301%, min. | |||
| Freedom from | |||
| holes | The purpose of the | ||
| test is to detect holes | |||
| in the gloves | No leakage at sampling level of | ||
| G-1, AQL 2.5 | Pass | ||
| No leakage, 80 of 80 passed |
8
| Residual
Powder | The purpose of the
test is to detect the
powder residue in
the glove |