(99 days)
Not Found
No
The device is a simple examination glove and the summary contains no mention of AI, ML, or any related computational processing.
No
The device is described as an examination glove intended to prevent contamination, not to provide therapeutic benefit.
No
Explanation: The device is an examination glove, intended to prevent contamination between patient and examiner. It does not perform any diagnostic function.
No
The device is a physical examination glove made of nitrile, not software. The description details material, dimensions, and physical performance tests.
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 "worn on the examiner's hands to prevent contamination between patient and examiner." This is a barrier function for infection control, not a diagnostic test performed on samples from the human body.
- Device Description: The description focuses on the physical characteristics of the glove (material, size, color, powder-free) and its function as a barrier.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information about a patient's health condition.
- Performance Studies: The performance studies focus on the physical properties and biocompatibility of the glove (freedom from holes, tensile strength, irritation, sensitization), which are relevant to its barrier function and safety for contact with skin, not diagnostic accuracy.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This glove does not fit that description.
N/A
Intended Use / Indications for Use
The Powder Free Nitrile Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
Product codes
LZA
Device Description
The proposed device, Powder Free Nitrile Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
The proposed devices are Powder Free Nitrile Examination Gloves and include variations of different sizes from X-Small to X-large. The color of the proposed device is Blue and Indigo
The proposed device is not provided as sterilized The proposed device is made of Nitrile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner's, medical purposes
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)
Bench tests were conducted to demonstrate that the proposed device complies with the following standards: ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application; ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves; ASTM D6124-17, Standard Test Method for Residual Powder on Medical Gloves; ISO 10993-10:2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization; ISO 10993-11:2017, Biological evaluation of medical devices - Part 11: Tests for systemic toxicity.
Key results:
- Freedom from holes (AQL:1.5): No water leakage is inspected form 200 samples.
- Powder residue: Average 0.38 Mg.
- Before Aging: Tensile Strength: greater than or equal to 17 MPa; Ultimate Elongation: greater than or equal to 512%.
- After Aging: Tensile Strength: greater than or equal to 17 MPa; Ultimate Elongation: greater than or equal to 508%.
- Length of Size XS: greater than or equal to 229 mm; Width of Size XS: greater than or equal to 70 (70-73) mm; Palm Thickness of Size XS: greater than or equal to 0.09 mm; Finger Thickness of Size XS: greater than or equal to 0.11 mm.
- Length of Size S: greater than or equal to 230 mm; Width of Size S: greater than or equal to 85 (85-86) mm; Palm Thickness of Size S: greater than or equal to 0.09 mm; Finger Thickness of Size S: greater than or equal to 0.11 mm.
- Length of Size M: greater than or equal to 230 mm; Width of Size M: greater than or equal to 95 (95-96) mm; Palm Thickness of Size M: greater than or equal to 0.09 mm; Finger Thickness of Size M: greater than or equal to 0.11 mm.
- Length of Size L: greater than or equal to 230 mm; Width of Size L: greater than or equal to 108 (108-110) mm; Palm Thickness of Size L: greater than or equal to 0.09 mm; Finger Thickness of Size L: greater than or equal to 0.11 mm.
- Length of Size XL: greater than or equal to 230mm; Width of Size XL: greater than or equal to 120 (120-121) mm; Palm Thickness of Size XL: greater than or equal to 0.09 mm; Finger Thickness of Size XL: greater than or equal to 0.11 mm.
- Systemic toxicity: Under the conditions of the study, the test article showed “negative” systemic toxicity.
- Irritation: Under the experimental conditions, the test article has no skin irritation on rabbits.
- Sensitization: The test article showed no evidence of causing delayed dermal contact sensitization in the guinea pig.
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 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.
June 29, 2022
Daxwell, LLC % Ray Wang Gerneral Manager Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District Beijing, Beijing 102401 China
Re: K220834
Trade/Device Name: Powder Free Nitrile Examination Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Non-powdered patient examination glove Regulatory Class: Class I, reserved Product Code: LZA Dated: May 19, 2022 Received: May 26, 2022
Dear Ray 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.
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,
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) K220834
Device Name Powder Free Nitrile Examination Glove
Indications for Use (Describe)
The Powder Free Nitrile Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hands 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 K220834
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) Number: K220834
-
- Date of Preparation: 06/29/2022
-
- Sponsor
DAXWELL, LLC
2825 Wilcrest Dr #500 Houston, TX 77042 US Contact Person: Frank Zhang Position: Head of Firm Tel: 01-281-699-0622 Fax: 01-281-699-0617 Email: scm.asst@Daxwell.com
- Submission Correspondent 3.
Beijing Believe-Med Technology Service Co., Ltd.
Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, Beijing, China,102401 Contact Person: Ray Wang Position: General Manager Tel: +86-18910677558 Fax: +86-10-56335780 Email:information(@believe-med.com
- Proposed Device Identification 4.
Trade Name: Powder Free Nitrile Examination Glove Common Name: Powder Free Nitrile Examination Glove Regulatory Information: Classification: I Product Code: LZA Regulation Number: 21 CFR 880.6250 Review Panel: General Hospital
4
Indication for Use Statement:
The Powder Free Nitrile Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
-
Predicate Device Identification 5.
510(k) Number: K212497 Product Name: Nitrile Examination Glove (Powder free, Blue) Manufacturer: Jiangsu Jinlian Medical Technology Co., Ltd -
Device Description 6.
The proposed device, Powder Free Nitrile Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
The proposed devices are Powder Free Nitrile Examination Gloves and include variations of different sizes from X-Small to X-large. The color of the proposed device is Blue and Indigo
The proposed device is not provided as sterilized The proposed device is made of Nitrile.
| Size
Model | Cuff
Thickness
(mm) | Palm
Thickness
(mm) | Finger
Thickness
(mm) | Width
(mm) | Length
(mm) | Color |
|---------------|---------------------------|---------------------------|-----------------------------|---------------|----------------|--------|
| XS | ≥ 0.05 | ≥ 0.05 | ≥ 0.05 | 70±10 | ≥ 220 | |
| S | ≥ 0.05 | ≥ 0.05 | ≥ 0.05 | 80±10 | ≥ 220 | Blue |
| M | ≥ 0.05 | ≥ 0.05 | ≥ 0.05 | 95±10 | | |
| L | ≥ 0.05 | ≥ 0.05 | ≥ 0.05 | 110±10 | ≥ 230 | |
| XL | ≥ 0.05 | ≥ 0.05 | ≥ 0.05 | 120±10 | | |
| XS | ≥ 0.05 | ≥ 0.05 | ≥ 0.05 | 70±10 | ≥ 220 | |
| S | ≥ 0.05 | ≥ 0.05 | ≥ 0.05 | 80±10 | ≥ 220 | |
| M | ≥ 0.05 | ≥ 0.05 | ≥ 0.05 | 95±10 | | Indigo |
| L | ≥ 0.05 | ≥ 0.05 | ≥ 0.05 | 110±10 | ≥ 230 | |
| XL | ≥ 0.05 | ≥ 0.05 | ≥ 0.05 | 120±10 | | |
Table 1 Device Size Specifications
5
| Before Aging | After Aging | Pinhole AQL | ||
|---|---|---|---|---|
| Tensile | ||||
| Strength | Ultimate | |||
| Elongation | Tensile | |||
| Strength | Ultimate | |||
| Elongation | 1.5 | |||
| 15 MPa, min | 500 % min | 14 MPa, min | 500 % min |
Table 2 Performance and Physical Specifications
7. Technological Characteristic Comparison Table
| Table 3 General Comparison | |
|---|---|
| ITEM | Proposed Device(K220834)
Powder Free Nitrile Examination Glove | Predicate Device (K212497)
Nitrile Examination Glove (Powder free,
Blue) | Remark |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Product Code | LZA | LZA | SAME |
| Regulation No. | 21 CFR 880.6250 | 21 CFR 880.6250 | SAME |
| Class | I | I | SAME |
| Intended Use /
Indications for
Use | The Powder Free Nitrile Examination
Glove is a disposable device intended for
medical purposes that is worn on the
examiner's hands to prevent contamination
between patient and examiner. | The Nitrile Examination Glove (Powder
free, Blue) is a disposable device intended
for medical purposes that is worn on the
examiner's hands to prevent contamination
between patient and examiner. | SAME |
| Sterility | Non-sterile | Non-sterile | SAME |
| Single use or
reuses | Single use | Single use | SAME |
| Powdered or
Powered free | Powdered free | Powdered free | SAME |
6
| Proposed Device (K220834) | Designation | Size | Tolerance | ||||
|---|---|---|---|---|---|---|---|
| Powder Free Nitrile | |||||||
| Examination Glove | |||||||
| (Blue, Indigo) | Length, mm | XS | S | M | L | XL | |
| 230 | 230 | 230 | 230 | 230 | ±10 | ||
| Width, mm | 70 | 80 | 95 | 110 | 120 | ±10 | |
| Thickness, mm: | |||||||
| Finger | 0.12 | ±0.03 | |||||
| Palm | 0.10 | ±0.03 | |||||
| Cuff | 0.09 | ±0.03 | |||||
| Predicate Device (K212497) | Designation | Size | Tolerance | ||||
| Nitrile Examination Glove | |||||||
| (Powder free, Purple-Blue, | |||||||
| Blue) | Length, mm | S | M | L | XL | min | |
| 230 | 230 | 230 | 230 | ||||
| Width, mm | 80 | 95 | 110 | 120 | ±10 | ||
| Thickness, mm: | |||||||
| Finger | 0.05 | min | |||||
| Palm | 0.05 | min | |||||
| Cuff | 0.05 | min | |||||
| Remark | Analysis 1 |
Table 4 Device Dimensions Comparison
Analysis 1:
The proposed device has different size specification to the predicate device, but all proposed devices meet the specifications of ASTM D 6319.
Table 5 Performance Comparison
| ITEM | | | Proposed Device(K220834)
Powder Free Nitrile Examination
Glove | Predicate Device (K212497)
Nitrile Examination Glove
(Powder free, Purple-Blue,
Blue) | Remark |
|------------------------|-----------------|------------------------|----------------------------------------------------------------------|------------------------------------------------------------------------------------------------|------------|
| Colorant | | | Blue, Indigo | Blue | Analysis 2 |
| Physical
Properties | Before
Aging | Tensile
Strength | 15 MPa, min | 14 MPa, min | Analysis 3 |
| | | Ultimate
Elongation | 500 % min | 500 % min | SAME |
| | After
Aging | Tensile
Strength | 14 MPa, min | 14 MPa, min | SAME |
| | | Ultimate | 500 % min | 400 % min | Analysis 4 |
7
| Elongation | |||||
|---|---|---|---|---|---|
| Comply with ASTM D6319 | Comply with ASTM D6319 | SAME | |||
| Freedom from Holes | Be free from holes when tested in | ||||
| accordance with ASTM D5151 | |||||
| (AQL:1.5) | Be free from holes when tested in | ||||
| accordance with ASTM D5151 | |||||
| (AQL:1.5) | SAME | ||||
| Powder Content | Less than 2 mg per glove when tested | ||||
| in accordance with ASTM D6124 | Less than 2 mg per glove when | ||||
| tested in accordance with ASTM | |||||
| D6124. | SAME |
Analysis 2:
The proposed device has different color to the predicate device, this difference may cause potential biocompatibility risk, for this risk we conducted the biocompatibility testing according to ISO 10993-11 and ISO 10993-10, the test results showed that the proposed devices with blue colorant and indigo colorant did not induce skin irritation, and showed no significant evidence of causing skin sensitization and acute system toxicity reactions.
Analysis 3:
The proposed device has different Tensile Strength before aging specification to the predicate device, but all proposed device meets the specification requirements of ASTM D 6319.
Analysis 4:
The proposed device has different Ultimate Elongation after aging specification to the predicate device, but all proposed device meets the specification requirements of ASTM D 6319.
| ITEM | Proposed Device(K220834) | Predicate Device (K212497) | Remark | |
|---|---|---|---|---|
| Powder Free Nitrile Examination | ||||
| Glove | Nitrile Examination Glove | |||
| (Powder free, Blue) | ||||
| Material | Nitrile | Nitrile | SAME | |
| Biocompatibility | Irritation | Under the conditions of the study, | ||
| not an irritant | Under the conditions of the study, | |||
| not an irritant | SAME | |||
| Sensitization | Under conditions of the study, not a | |||
| sensitizer. | Under conditions of the study, not a | |||
| sensitizer. | ||||
| Systemic | ||||
| toxicity | Under conditions of the study, not a | |||
| systemic toxicity | Under conditions of the study, not a | |||
| systemic toxicity | ||||
| Label and Labeling | Meet FDA's Requirements | Meet FDA's Requirements | SAME |
Table 6 Safety Comparison
8
8.0 Summary of Non-Clinical Testing
Bench tests were conducted to demonstrate that the proposed device complies with the following standards:
ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application.
ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves.
ASTM D6124-17, Standard Test Method for Residual Powder on Medical Gloves.
ISO 10993-10:2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
ISO 10993-11:2017, Biological evaluation of medical devices - Part 11: Tests for systemic toxicity.
| Test
| Method | Purpose | Acceptance Criteria | Color | Results |
|---|---|---|---|---|
| ASTM | ||||
| D5151 | Testing for Freedom from holes | Freedom from holes (AQL:1.5) | Blue | |
| Indigo | No water leakage is inspected | |||
| form 200 samples | ||||
| ASTM | ||||
| D6124 | Determine the powder residue for powder free gloves |