(112 days)
No
The device is a simple examination glove and the summary contains no mention of AI, ML, or related concepts.
No.
The device, a nitrile examination glove, is intended to prevent contamination between patient and examiner, which is a barrier function, not a therapeutic action like treating or alleviating a disease or condition.
No.
The device (a nitrile examination glove) is intended to prevent contamination, not to diagnose a medical condition.
No
The device described is a physical examination glove, not a software application. The summary details physical properties and performance testing of a tangible product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "to prevent contamination between patient and examiner." This describes a barrier function for personal protection, not a diagnostic test performed on samples taken from the body.
- Device Description: The description reinforces the intended use as a barrier worn on the hand.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting substances, or providing information for diagnosis, monitoring, or treatment decisions based on in vitro analysis.
- Performance Studies: The performance studies focus on the physical properties and biocompatibility of the glove itself (watertightness, tensile strength, irritation, etc.), which are relevant to its function as a barrier, not its diagnostic capability.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health. This device does not fit that description.
N/A
Intended Use / Indications for Use
Nitrile powder free examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Product codes
LZA
Device Description
Nitrile powder free examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. This glove is in blue color, non-sterile and can be available in four specifications: Small, Medium, Large, X meets all of the requirements of ASTM standard D 6139-19.
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 (medical purpose)
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 met all design specifications. The test results demonstrated that the proposed device complies with the following standards: ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-11, ASTM D6124-06, ASTM D5151-19, ASTM D6319-19.
Key results include:
- Physical Dimensions Test (ASTM D6319) showed various sizes met specifications.
- Watertightness Test for Detection of Holes (ASTM D5151) showed no water leakage (0/125/Pass).
- Powder Content (ASTM D6124) was 0.3-0.4mg/Pass (
§ 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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue rectangle with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 18, 2022
Hebei kangxida Medical Technology Development Co., Ltd. % Bryan Wong Associate PureVision Ai Inc. 111 Town Square Place. Suite 1203 Jersey, New Jersey 07310
Re: K220211
Trade/Device Name: Nitrile Powder Free Examination Gloves (YK0001) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: March 29, 2022 Received: April 5, 2022
Dear Bryan Wong:
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 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 Qian, M.D., Ph.D. Acting Assistant Director 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
2
Indications for Use
510(k) Number (if known) K220211
Device Name
Nitrile Powder Free Examination Gloves (YK0001)
Indications for Use (Describe)
Nitrile powder free examination glove is a disposable device intended for medical purpose 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)
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:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary K220211
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
1. Submitter's Information
Sponsor
- Company Name: Hebei Kangxida Medical Technology Development Co., Ltd. �
- Address: No. 5, Chuangye Avenue, Weixian Economic Development Zone, Handan City, Hebei � Province, China
- Phone: +86-15033056781 �
- � Email: handanyingke@163.com
- � Contact Person (including title): Liu Xiaomin (General Manager)
- Date of Preparation: Jan. 24, 2022 �
Application Correspondent:
- � PureFDA
- Address: 111 Town Square Place, Suite 1203 Jersey City, NJ 07310-2784 �
- Contact Person: Bryan Wong �
- Title: Associate �
- � Tel: +1 888 768 1688
- � Email: bryan@purefda.com
2. Subject Device Information
- � Type of 510(k) submission: Traditional
- Common Name: Patient Examination gloves �
- Classification Name: Non-powdered Patient examination glove �
- Trade Name: Nitrile Powder Free Examination Gloves �
- � Model: YK0001
- Review Panel: General Hospital �
- Product Code: LZA �
- Regulation Number: 21 CFR 880.6250 �
- � Requlation Class: I
3. Predicate Device Information
- 510(k) number: K120970 �
- � Sponsor: Tangshan Zhonghong Pulin Plastic Co., Ltd.
4
- Common Name: Patient Examination gloves �
- Classification Name: Patient examination glove �
- Trade Name: Powder Free Nitrile Patient Examination Gloves, Blue Color �
- � Review Panel: General Hospital
- Product Code: LZA �
- Regulation Number: 21 CFR 880.6250 �
- Regulation Class: I �
4. Device Description
Nitrile powder free examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. This glove is in blue color, non-sterile and can be available in four specifications: Small, Medium, Large, X meets all of the requirements of ASTM standard D 6139-19.
5. Intended Use / Indications for Use
Nitrile powder free examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
6. Comparison to predicate device
| Device | Proposed Device | Predicate Device | Comparison |
|---|---|---|---|
| 510(K) | K220211 | K120970 | -- |
| Manufacturer | Hebei Kangxida Medical Technology | ||
| Development Co., Ltd. | Tangshan Zhonghong Pulin Plastic | ||
| Co., Ltd. | -- | ||
| Product Name | Nitrile Examination Gloves | Powder Free Nitrile Patient | |
| Examination Gloves, Blue Color | -- | ||
| Regulation | |||
| Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Class | I | I | Same |
| Product Code | LZA | LZA | Same |
| Color | Blue | Blue | Same |
| Size | Small/ Medium/ Large/X large | Small/ Medium/ Large/X large | Same |
| Design Feature | ambidextrous | ambidextrous | Same |
| Surface Feature | Smooth | Smooth | Same |
| Intended Use/ | Nitrile powder free examination glove | Powder Free Nitrile Patient | Same |
Table 1-General Comparison
5
| Indications for Use | is a disposable device intended for
medical purpose that is worn on the
examiner's hand or finger to prevent
contamination between patient and
examiner. | | | | Examination Glove, Blue Color 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. | | | | |
|-----------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|--------|-----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|------------------|-------------------|--|
| Device Description
and Specifications | Meets ASTM D6319- 19 | | | | Meets ASTM D6319- 10 | | | Same | |
| Dimensions-
Length
ILS-2 AQL4.0
(ASTM D6319) | ≥230mm min for Small sizes
≥240mm min for Medium / Large / X
large sizes | | | | Meets ASTM
D6319-10
≥230mm min | | | | |
| Dimensions-
Width
IL S-2 AQL4.0
(ASTM D6319) | Small | 85mm±10mm | | Small | 70-90 mm | | Similar | | |
| | Medium | 95mm±10mm | | Medium | 85-105mm | | Note 1 | | |
| | Large | 105mm±10mm | | Large | 100-120mm | | | | |
| | X large | 115mm±10mm | | X large | 110-130 mm | | | | |
| Dimensions-
Thickness
IL S-2 AQL4.0
(ASTM D6319) | Finger | Thickness (mm)
min. Finger 0.05 | | Finger | 0.05mm min | | | | |
| | Palm | Thickness (mm)
min. Palm 0.05 | | Palm | 0.05mm min. | | | | |
| | Before
Aging | Tensile
Strength | ≥14MPa | Before
Aging | Tensile
Strength | ≥14MPa | Similar
Note2 | | |
| Physical
Properties IL S-2
AQL4.0
(ASTM D6319) | | Ultimate
Elongation | ≥500% | | Ultimate
Elongation | ≥500% | | | |
| | After
Aging | Tensile
Strength | ≥14MPa | After
Aging | Tensile
Strength | ≥14MPa | | | |
| | | Ultimate
Elongation | ≥400% | | Ultimate
Elongation | ≥400% | | | |
| Freedom from
Pinholes
Inspection Level I
AQL2.5
(ASTM D5151-06) | Meets
• 21 CFR 800.20
• ASTM D6319-19 | | | | Meets
• 21 CFR 800.20
• ASTM D6319-10 | | | Same | |
| Residual Powder
(ASTM D 6124-06) | Meets ASTM
D 6124-06
(Reaffirmation 2011)
below 2mg of residual powder | | | | Meets ASTM
D 6124-06
(Reaffirmation 2011)
below 2mg of residual powder | | | | |
| Biocompatibility | Under the conditions of this study, the
test article was a non irritant , non
sensitizer and non Systemic Toxicity | | | | Under the conditions of this study, the
test article was a nonirritant or
nonsensitizer | | | Similar
Note 3 | |
6
Comparison in Detail(s):
Note 1:
The difference in the dimensions does not raise additional questions for safety and effectiveness. All proposed devices are conducted the test according to ASTM D6319, the test results shown that the dimension of proposed device meet the requirements of standard.
Note 2:
The difference in the physical properties does not raise additional questions for safety and effectiveness. Proposed devices are conducted the test according to ASTM D6319, the test results shown that the physical properties of proposed device meet the requirements of standard.
Note 3:
Performance testing including biocompatibility evaluation has been performed on the proposed device. The test results shown that the performance of proposed device meet the requirements of standard and no potential biocompatibility issues.
7. Summary for non-clinical testing
Non-clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:
ISO 10993-1 Fifth edition 2018-08: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
ISO 10993-5 Third edition 2009-06-01 Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity
ISO 10993-10 Third Edition 2010-08-01 Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization
ISO 10993-11 Third edition 2017-09 Biological evaluation of medical devices – Part 11: Tests for systemic toxicity
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
ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application
7
| Test Method | Purpose | Acceptance Criteria | Results | |||
|---|---|---|---|---|---|---|
| ASTM D6319 | Physical | |||||
| Dimensions Test | Length(mm) | |||||
| Small: ≥230mm | ||||||
| Medium: ≥230mm | ||||||
| Large: ≥230mm | ||||||
| X large: ≥230mm | Length(mm) | |||||
| Small: 231-238/Pass | ||||||
| Medium: 244-248/Pass | ||||||
| Large: 245-249/Pass | ||||||
| X large: 240-244/Pass | ||||||
| Width(mm) | ||||||
| Small: 85±10mm | ||||||
| Medium: 95±10mm | ||||||
| Large: 110±10mm | ||||||
| X large: 115±10mm | Width(mm) | |||||
| Small: 85-86/Pass | ||||||
| Medium: 96-97/Pass | ||||||
| Large: 106-108/Pass | ||||||
| X large: 113-114/Pass | ||||||
| Thickness (mm) | ||||||
| Finger | ||||||
| Small: ≥0.05mm | ||||||
| Medium: ≥0.05mm | ||||||
| Large: ≥0.05mm | ||||||
| X large: ≥0.05mm | Thickness (mm) | |||||
| Finger | ||||||
| Small: 0.097-0.111/Pass | ||||||
| Medium: 0.110-0.131/Pass | ||||||
| Large: 0.110-0.129/Pass | ||||||
| X large: 0.116-0.128/Pass | ||||||
| Palm | ||||||
| Small: ≥0.05mm | ||||||
| Medium: ≥0.05mm | ||||||
| Large: ≥0.05mm | ||||||
| X large: ≥0.05mm | Palm | |||||
| Small: 0.064-0.068/Pass | ||||||
| Medium: 0.065-0.069/Pass | ||||||
| Large: 0.060-0.065/Pass | ||||||
| X large: 0.059-0.066/Pass | ||||||
| ASTM D5151 | Watertightness | |||||
| Test for Detection | ||||||
| of Holes | No water leakage | 0/125/Pass | ||||
| ASTM D6124 | Powder Content |