(69 days)
Not Found
No
The device is a standard medical examination glove, and the summary focuses on physical and biocompatibility testing, with no mention of AI or ML.
No
The device, a medical examination glove, is intended to prevent contamination between the patient and examiner, which is a barrier function, not a therapeutic function.
No
The device, Medical Examination Glove (Nitrile), is described as a disposable device worn on the examiner's hand to prevent contamination. Its function is to provide a barrier, not to analyze medical data or diagnose conditions.
No
The device is a physical medical examination glove made of nitrile, not a software application. The description focuses on material properties, physical performance, and biocompatibility testing, which are characteristic of a hardware device.
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 a "disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner." This describes a barrier device for infection control, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or treatment.
- Device Description: The description focuses on the physical properties and standards related to gloves (material, size, color, standards like ASTM D6319-19). There is no mention of analyzing biological samples or providing diagnostic information.
- Performance Studies: The performance studies listed are related to biocompatibility and physical properties of the glove (irritation, sensitization, toxicity, tensile strength, freedom from holes, residual powder). These are relevant to the safety and effectiveness of a barrier device, not the analytical or clinical performance of a diagnostic test.
- Key Metrics: The document explicitly states "Not Applicable" for key metrics like Sensitivity, Specificity, PPV, NPV, etc., which are standard metrics for evaluating the performance of diagnostic devices.
In summary, the device's purpose is to act as a physical barrier, not to perform a diagnostic test on a biological sample. Therefore, it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Medical Examination Glove (Nitrile) is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Product codes (comma separated list FDA assigned to the subject device)
LZA
Device Description
The Medical Examination Gloves (Nitrile) are non-sterile, single use only, disposable examination gloves intended for medical purposes to be worn by examiners to prevent contamination between the patient and the examiner. The gloves are blue color, powder free, nitrile ambidextrous gloves are offered in sizes extra-small, small, medium, large, extra-large packed in a paper box.
The gloves are designed and manufactured in accordance with the ASTM D6319-19 standard.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand
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 Testing:
Biocompatibility:
- ISO 10993-10: Primary Skin Irritation - Results: Pass (Under the conditions of the study, not an irritant.)
- ISO 10993-10: Dermal Sensitization - Results: Pass (Under the conditions of the study, not a sensitizer.)
- ISO 10993-11: Acute Systemic Toxicity - Results: Pass (Under the conditions of the study, the device is non-toxic.)
Performance Testing:
- Dimensions (width, thickness, length) per ASTM D6319-19: Results: Pass (76mm min width, 234mm min length, Palm - 0.08mm min, Finger-0.09mm min).
- Physical properties (tensile strength and ultimate elongation before and after aging) per ASTM D6319-19: Results: Pass (Tensile Strength: Before Aging 24.44 MPa, min. After Aging 27.21 MPa, min. Elongation: Before Aging 513%, min. After Aging 541%, min.)
- Freedom from holes per ASTM D5151-19: Results: Pass (No leakage, 80 of 80 passed of each size).
- Residual Powder per ASTM D6124-06: Results: Pass (average 0.84 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, there is a seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged in a circular pattern. To the right of the seal, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on top and "ADMINISTRATION" below. The logo is simple and professional, reflecting the FDA's role in regulating food and drugs.
October 26, 2022
Humanwell Healthcare Group Medical Supplies Co., Ltd. % Ivy Wang Technical Manager Shanghai Sungo Management Consulting Company Limited 14th F, 1500# Century Avenue Shanghai. 200122 China
Re: K222498
Trade/Device Name: Medical Examination Gloves (Nitrile) (XS, S, M, L, XL) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: August 18, 2022 Received: August 18, 2022
Dear Ivy Wang:
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.
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
1
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 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).
Sincerely,
Bifeng Oian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
Submission Number (if known)
Device Name
Medical Examination Gloves (Nitrile) (XS, S, M, L, XL)
Indications for Use (Describe)
The Medical Examination Glove (Nitrile) is a disposable device intended for medical purposes that is worn on the examiner's hand 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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3
510(K) Summary
(As requirement by 21 CFR 807.92)
Date prepared: 2022-10-25
A. Applicant:
Name: Humanwell Healthcare Group Medical Supplies Co., Ltd.
Address: 169 Shendun Yi Lu, East Lake Hi-tech Development Zone, Wuhan, Hubei Province, People's Republic of China Contact: Ms. Aixue Yao
Title: Sales Manager
Tel: +86- 18627726855
Email: 674599374@qq.com
Submission Correspondent: Primary contact: Ms. Ivy Wang Shanghai SUNGO Management Consulting Co., Ltd. Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: haiyu.wang@sungoglobal.com Secondary contact: Mr. Raymond Luo Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: fda.sungo@gmail.com
B. Device:
Trade Name: Medical Examination Gloves (Nitrile) (XS, S, M, L, XL) Common Name: Nitrile Patient Examination Gloves (Powder Free)
Regulatory Information Classification Name: Polymer Patient Examination Glove Classification: Class I Product code: LZA Regulation Number: 21 CFR 880.6250 Review Panel: General Hospital
C. Predicate device:
K171422 Disposable Powder Free Nitrile Examination Glove, White/Blue/ Black/ Pink Color Ever Global (Vietnam) Enterprise Corp
D. Indications for use of the device:
The Medical Examination Glove (Nitrile) is a disposable device intended for medical purposes that is worn on
4
K222498
the examiner's hand to prevent contamination between patient and examiner.
E. Device Description:
The Medical Examination Gloves (Nitrile) are non-sterile, single use only, disposable examination gloves intended for medical purposes to be worn by examiners to prevent contamination between the patient and the examiner. The gloves are blue color, powder free, nitrile ambidextrous gloves are offered in sizes extra-small, small, medium, large, extra-large packed in a paper box.
The gloves are designed and manufactured in accordance with the ASTM D6319-19 standard.
F. Summary of Technological Characteristics
Table 1 General Comparison of Proposed and Predicate Devices
| Device | Proposed Device | Predicate Device | Result |
|---|---|---|---|
| 510K # | K222498 | K171422 | - |
| Product Name | Medical Examination Gloves (Nitrile) | Disposable | |
| Powder | |||
| Free | |||
| Nitrile | |||
| Examination | |||
| Glove, | |||
| White/Blue/ | |||
| Black/ Pink Color | - | ||
| Product Code | LZA | LZA | Same |
| Regulation | |||
| Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Indications | |||
| for | |||
| use | The Medical Examination Glove (Nitrile) is a | ||
| disposable device intended for medical | |||
| purposes that is worn on the examiner's hand | |||
| to prevent contamination between patient | |||
| and examiner. | The Disposable Powder Free Nitrile | ||
| Examination Glove, White/ Blue/ Black/ | |||
| Pink Color is a disposable device | |||
| intended for medical purposes that is | |||
| worn on the examiner's hands to | |||
| prevent contamination between patient | |||
| and examiner. | Same | ||
| Powder free | Yes | Yes | Same |
| Design feature | Ambidextrous | Ambidextrous | Same |
| Material | Nitrile | Nitrile | Same |
| OTC use | Yes | Yes | Same |
| Sterility | Non-sterile | Non-sterile | Same |
| Use | Single use | Single use | Same |
| Label | Single-use, indication, powder free, device | ||
| color, device name, glove size and quantity, | |||
| Nitrile Glove Powder Free Blue, Non-Sterile | Single-use, indication, powder free, | ||
| device color, device name, glove size and | |||
| quantity, Disposable Powder Free | |||
| Nitrile Examination Glove, Non-Sterile | Same |
Table 2 Device dimension comparison
| Predicate
device
| (K171422) | Designation | Size | Tolerance | ||||
|---|---|---|---|---|---|---|---|
| XS | S | M | L | XL | |||
| Length, mm | 230 | 230 | 230 | 230 | 230 | min | |
| Width, mm | 75 | 85 | 90 | 105 | 115 | $\u00b15$ |
5
| Thickness, mm | |||||||
|---|---|---|---|---|---|---|---|
| Finger | 0.05 min | ||||||
| Palm | 0.05 min | ||||||
| Proposed | |||||||
| device | Designation | Size | Tolerance | ||||
| XS | S | M | L | XL | |||
| Length, mm | 220 | 220 | 230 | 230 | 230 | min | |
| Width, mm | 70 | 80 | 95 | 110 | 120 | $\pm$ 10 | |
| Thickness, mm | |||||||
| Finger | 0.05 min | ||||||
| Palm | 0.05 min | ||||||
| Result | Similar |
Analysis: The physical dimensions are different with that of the predicate, but they all meet the requirements of ASTM D6319-19, so the differences do not raise any new safety or performance questions.
| Item | Proposed device | Predicate device (K171422) | Result | |
|---|---|---|---|---|
| Colorant | Blue | White/ Blue/ Black/ Pink | Similar | |
| Physical properties | Before aging Tensile strength | 14MPa, min | 14MPa, min | Same |
| Ultimate elongation | 500%, min | 500%, min | Same | |
| After aging Tensile strength | 14MPa, min | 14MPa, min | Same | |
| Ultimate elongation | 400%, min | 400%, min | Same | |
| Comply with ASTM D6319 | Comply with ASTM D6319 | Same | ||
| Freedom from holes | Be free from holes when tested in accordance with ASTM D5151 G-1, AQL 2.5 | Be free from holes when tested in accordance with ASTM D5151 G-1, AQL 2.5 | Same | |
| Residual Powder | Meet the requirements of ASTM D6124 | Meet the requirements of ASTM D6124 | Same |
Table 3 Performance comparison
Analysis: The subject device is only available in a single color (blue,) however, the predicate is available in multiple colors (white, blue, black, pink). Biocompatibility testing was successfully completed for the subject device, demonstrating that any color differences do not affect the safety of the proposed device.
Table 4 Biocompatibility comparison
| Item | | Proposed device | Predicate device
(K171422) | Result |
|------------------|----------------------------|--------------------------------|-------------------------------|--------|
| Material | | Nitrile | Nitrile | Same |
| Biocompatibility | Irritation
ISO 10993-10 | Under the
conditions of the | Comply with ISO
10993-10 | Same |
6
| | study, not an
irritant. Comply
with ISO 10993-10. | |
|--------------------------------------------|--------------------------------------------------------------------------------------------|-----------|
| Sensitization
ISO 10993-10 | Under the
conditions of the
study, not a
sensitizer. Comply
with ISO 10993-10. | |
| Acute systemic
toxicity
ISO 10993-11 | Under the /
conditions of the
study, the device is
non-toxic. | Different |
Analysis: Toxicity information for the predicate device is not publicly available. This does not raise different safety or performance questions since the subject device has acceptable biocompatibility per the biocompatibility endpoint assessment.
G. Summary of Non-Clinical Testing
A Biocompatibility
The following tests for the subject device were conducted the biocompatibility of Medical Nitrile Examination Gloves:
- ISO 10993-10: Primary Skin Irritation
- ISO 10993-10: Dermal Sensitization
- · ISO 10993-11: Acute Systemic Toxicity
| Test | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| Irritation | |||
| ISO 10993-10 | The purpose of the test is to verify | ||
| that the proposed device extract is | |||
| non-irritating. | Under the conditions of the | ||
| study, not an irritant. | Pass | ||
| Sensitization | |||
| ISO 10993-10 | The purpose of the test is to verify | ||
| that the proposed device extract is | |||
| non-sensitizing | Under the conditions of the | ||
| study, not a sensitizer. | Pass | ||
| Acute systemic | |||
| toxicity | |||
| ISO 10993-11 | The purpose of the test is to verify | ||
| that the proposed device extract is | |||
| non-cytotoxic. | Under the conditions of the | ||
| study, the device is non-toxic. | Pass |
A Performance Testing
Physical performance testing of the proposed device was conducted as per ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.
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 D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application
- ASTM D6124-06 (Reapproved 2017) Standard Test Method for Residual Powder on Medical Gloves
7
K222498
| Test Method | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| Dimensions (width) | |||
| (thickness) | The purpose of the | ||
| test is to evaluate | |||
| the physical | |||
| dimension of the | |||
| glove | Width 70mm min | ||
| Length 220mm min | |||
| Palm - 0.05mm min. | |||
| Finger-0.05mm min. | Pass | ||
| 76mm min width | |||
| 234mm min length | |||
| Pass | |||
| Palm - 0.08mm min. | |||
| Finger-0.09mm min | |||
| Physical properties | The purpose of the | ||
| test is to evaluate | |||
| the tensile strength | |||
| and ultimate | |||
| elongation before | |||
| and after aging | Tensile Strength: | ||
| Before Aging $\geq$ 14 MPa, min. | |||
| After Aging $\geq$ 14 MPa, min. | |||
| Elongation: | |||
| Before Aging 500%, min. | |||
| After Aging 400%, min. | Pass | ||
| Tensile Strength: | |||
| Before Aging 24.44 MPa, min. | |||
| After Aging 27.21 MPa, min. | |||
| Elongation: | |||
| Before Aging 513%, min. | |||
| After Aging 541%, 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 of | |||
| each size | |||
| Residual Powder | The purpose of the | ||
| test is to detect the | |||
| powder residue in | |||
| the glove |