(58 days)
Not Found
No
The device is a disposable examination glove and the description and testing focus on material properties and physical performance, with no mention of AI/ML.
No
The device, Disposable Medical Nitrile Examination Gloves, is described as a patient examination glove worn to prevent contamination between patient and examiner, which is a barrier function, not a therapeutic one.
No
The device, Disposable Medical Nitrile Examination Gloves, is intended to prevent contamination and is used for examination purposes. It does not perform any diagnostic function such as detecting, diagnosing, treating, or preventing disease, nor does it provide information for diagnosis.
No
The device is a physical product (nitrile gloves) and the description focuses entirely on its material properties and performance as a physical barrier, with no mention of software components.
No, 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 purpose 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 from the human body.
- Device Description: The description reinforces its function as a "patient examination glove" worn on the hand for contamination prevention.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
- Measuring biomarkers or analytes
The device is a medical glove, which falls under a different regulatory classification than IVDs.
N/A
Intended Use / Indications for Use
The Disposable Medical Nitrile Examination Gloves is disposable device intended for medical purpose 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
Disposable Medical Nitrile Examination Gloves (Model: XYS-001, Size Large) is a patient examination qlove and it is made from nitrile compound. It is a single-use, powder-free and nonsterile product. The glove is worn on the examiner's hand to prevent contamination between patient and examiner, and this device meets all the requirement specifications in the ASTM D6319-19 Standard.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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)
Clinical test:
Clinical testing is not required.
Non-clinical data
The following bench testing was conducted to demonstrate that the subject device met the performance specification or the acceptance criteria in the standard or the test methodology provided below in the table. The results demonstrate that the subject device met the performance specification and the acceptance criteria for the respected standard and test method below : Performance:
- ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.
- Freedom from Holes- Testing for freedom from holes were conducted in accordance with Test Method ASTM D5151.
- Physical Dimension test -Determine the dimension as directed in Table 2 of ASTM D6319-19.
- Physical Requirement Test-Before and accelerated aging, the physical requirement specified in Table 3 of ASTM D6319-19, tests were conducted in accordance with test method ASTM D412 and accelerated aging test were conducted in accordance with Test Method ASTM D573.
- Powder Free Gloves-Determine the powder residue in accordance with Test Method ASTM D6124.
Biocompatibility:
- 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.
- ISO 10993-5:2009 Biological evaluation of medical devices - Part 5 Tests for In vitro cytotoxicity
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Performance:
Freedom from holes: 200 samples tested, 0 failures, Pass
Physical Dimension test: 13 samples tested/size, 0 failure, Pass
Physical Requirement Test: 13 samples tested/L size, 0 failure, Pass
Powder Free Gloves: 5pcs sample quantity, Average: 0.5mg, Pass
Biocompatibility:
In Vitro Cytotoxicity: Under the condition of the test, the test article was found to be cytotoxic.
Skin Sensitization: Under the condition of the test, the test article was found to be non-sensitizing.
Intracutaneous reactivity: the result showed that the polar and non-polar extract of the final test sample score is less 1.0.
Acute systemic toxicity: Under the condition of the test, the test article was found to be non-systemic toxicity.
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). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
December 9, 2021
Anhui Xinyisheng Medical Technology Co.,Ltd % Dave Yungvirt, CEO Official Correspondent THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren, NJ 07059
Re: K213371
Trade/Device Name: Disposable Medical Nitrile Examination Gloves (Model:XYS-001) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-powdered patient examination glove Regulatory Class: Class I, reserved Product Code: LZA Dated: November 29, 2021 Received: December 2, 2021
Dear Dave Yungvirt :
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 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,
For Clarence W. Murray, III, PhD 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) K213371
Device Name
Disposable Medical Nitrile Examination Gloves(Model:XYS-001)
Indications for Use (Describe)
The Disposable Medical Nitrile Examination Gloves is disposable device intended for medical purpose 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)
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3
510(K) Summary
Prepared in accordance with the requirements of 21 CFR Part 807.92
Prepared Date: Oct.11, 2021
1. Submitter's Information
The submitter of this pre-market notification is:
| Name: | Anhui Xinyisheng Medical Technology Co.,Ltd |
|---|---|
| Address: | No.999 North of the intersection of Tonghe Road and G343 |
| Road Si County Suzhou City, Anhui Province, China | |
| Contact person: | Shyla Tang |
| Title: | Manager |
| E-mail: | shyla@xinlingroup.com |
| Tel: | 86-18012883846 |
2. Device Identification
| 510(K) number: | K213371 |
|---|---|
| Trade/Device Name: | Disposable Medical Nitrile Examination Gloves |
| Size of glove | Large |
| Models: | XYS-001 |
| Common name: | Polymer Patient Examination Glove |
| Regulation Number: | 880.6250 |
| Regulation Name: | Non-powdered patient examination glove |
| Regulation Class: | Class I |
| Panel: | General Hospital |
| Product Code: | LZA |
3. Predicate Device
| 510(K) number: | K192333 |
|---|---|
| Device Name: | Blue Nitrile Examination Gloves Powder Free |
| Manufacturer: | JR Engineering & Medical Technologies (M) SDN.BHD |
| Common name | Polymer Patient Examination Glove |
| Regulation Number: | 880.6250 |
| Regulation Name: | Non-powdered patient examination glove |
| Regulation Class: | Class I |
| Panel: | General Hospital |
| Product Code: | LZA |
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4. Device Description
Disposable Medical Nitrile Examination Gloves (Model: XYS-001, Size Large) is a patient examination qlove and it is made from nitrile compound. It is a single-use, powder-free and nonsterile product. The glove is worn on the examiner's hand to prevent contamination between patient and examiner, and this device meets all the requirement specifications in the ASTM D6319-19 Standard.
5. Indication for use
The Disposable Medical Nitrile Examination Gloves is disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
6. Summary of the technological characteristics of the device compared to the Predicate Device
Compared to the predicate device, the subject device has the same intended use, similar product design, and similar performance as the predicate device, the summarized comparison information is listed in the following table:
| SE Comparisons | Subject Device | Predicate Device
K192333 | Remarks | |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|
| Name | Disposable Medical Nitrile
Examination Gloves | Blue Nitrile Examination
Gloves Powder Free | / | |
| Model | XYS-001 | / | / | |
| Size | Large | Extra Small, Small,
Medium, Large, Extra
Large | See Note1 | |
| Classification | Class I | Class I | Same | |
| Intended use | The Disposable Medical
Nitrile Examination Gloves
is disposable device
intended for medical
purpose that is worn on
the examiner's hand to
prevent contamination
between patient and
examiner. | JR MEDIC Blue Nitrile
Examination Gloves
Powder Free is
disposable devices
intended for medical
purpose that are worn on
the examiner's hand to
prevent contamination
between patient and
examiner. | Same | |
| Dimensions | ASTM D6319-
19 | Length Min:230mm
Width Min:110±10mm
(for Large size) | Length Min 230 mm
Width Min 95±10mm
(for medium size) | Note1 |
| Physical
Properties | ASTM D6319-
19 | Before Aging
Tensile Strength Min 14
Mpa
Ultimate Elongation Min
500%
After Aging
Tensile Strength Min 14
Mpa
Ultimate Elongation Min
400% | Same | |
| Thickness | ASTM D6319-
19 | Palm Min 0.05 mm
Finger Min 0.05 mm | Palm Min 0.05 mm
Finger Min 0.05 mm | Same |
| Powder Free | ASTM D6319-
19 | ≤2 mg/glove | ≤2 mg/glove | Same |
| Biocompatibility | ISO 10993-
10:2010 | / | Under the condition of
study not an
irritant | Note 2 |
| | ISO 10993-
10:2010 | Under the conditions of
the study, the result shows
no
Intracutaneous Reactivity | / | |
| | ISO 10993-
10:2010 | Under the conditions of
the study not a sensitizer | Under the conditions of
the study not a sensitizer | Same |
| | ISO 10993-
5:2009 | Under the conditions of
the study,
cytotoxic.
Additional testing was
performed to determine if
this was a systemic
toxicity concern | Under the conditions of
the study,
cytotoxic.
Additional testing was
performed to determine if
this was a systemic
toxicity concern | Same
Note 3 |
| | ISO 10993-
11:2017 | Under the condition of
study the device extracts
do not pose a systemic
toxicity concern | Under the condition of
study the device extracts
do not pose a systemic
toxicity concern | Same
Note 3 |
| | ISO 10993-
11:2017 | / | Under the conditions of
the study, the device did
not demonstrate a
material mediated
pyrogenicity response. | Note 4 |
| Power free | | Yes | Yes | Same |
| Single Use | | Yes | Yes | Same |
| Non-Sterile | | Yes | Yes | Same |
| Color | | Blue | Blue | Same |
| Intended use population | | Adult | Adult | Same |
| Wear | | ambidextrous | ambidextrous | Same |
| EXPIRE DATE | | Not claim | Included | See Note 5 |
5
Note 1:
In this submission, only one size "L" of glove was submitted for clearance and this size "L" of glove has been performed the testing according to the ASTM D6319-19,
Note 2:
According to the ISO 10993-10:2010, we conducted Intracutaneous reactivity test, Note 3:
6
We evaluated the In vitro cytotoxicity in accordance with ISO 10993-5:2009s. Additionally we evaluated acute systemic toxicity in accordance with ISO 10993-11:2017.
Note 4:
We do not claim "non-pyrogenic" and we evaluated the biocompatibility per ISO 10993-1, the material mediated pyrogenicity testing is unnecessary.
Note 5:According to FDA guidance, claiming shelf life is non-mandatory.
7. Performance Data
Clinical test:
Clinical testing is not required.
Non-clinical data
The following bench testing was conducted to demonstrate that the subject device met the performance specification or the acceptance criteria in the standard or the test methodology provided below in the table. The results demonstrate that the subject device met the performance
specification and the acceptance criteria for the respected standard and test method below : Performance:
- ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.
Freedom from Holes- Testing for freedom from holes were conducted in accordance with 2. Test Method ASTM D5151.
- Physical Dimension test -Determine the dimension as directed in Table 2 of ASTM D6319-19.
Physical Requirement Test-Before and accelerated aging, the physical requirement 4. specified in Table 3 of ASTM D6319-19, tests were conducted in accordance with test method ASTM D412 and accelerated aging test were conducted in accordance with Test Method ASTM D573.
- Powder Free Gloves-Determine the powder residue in accordance with Test Method ASTM D6124.
| Stand ard | Test item | Test
method | Criteria | Result | Conclusion |
|-------------------|----------------------------------|-------------------------|------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|---------------------------------------------|
| ASTM D6319
-19 | freedom
from holes | ASTM D5151 | Any glove that shows a
droplet, stream, or
other type of water
leakage shall be
considered to have
failed the test. | Did not show a
droplet, stream,
or other type of
water leakage | 200
samples tested
0 failures
Pass |
| | Physical
Dimension
test | ASTM D412
ASTM D3767 | L size
Width:95±10mm
Length:230min
Thickness:
Finger 0.05min
Palm 0.05min | Width:
110mm
Length:
237mm
Thickness:
Finger 0.142mm
Palm 0.082mm | 13 samples tested/size
0 failure
Pass |
| | Physical
Requiremen
t Test | ASTM D412
ASTM D573 | Tensile Strength:
Before Aging 14 Mpa,
min. | Tensile Strength:
Before Aging
19.1 Mpa, | 13 samples
tested/L size |
7
| | | | After Aging 14 Mpa,
min.
Elongation:
Before Aging 500%
After Aging 400% min. | After Aging 25.4
Mpa, Elongation:
Before Aging 508%
After Aging 517% | 0 failure Pass |
|--|-----------------------|------------|------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|----------------|
| | Powder
Free Gloves | ASTM D6124 | Max. 2.0mg | sample quantity:
5pcs
Average: 0.5mg | Pass |
Biocompatibility:
-
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.
-
ISO 10993-5:2009 Biological evaluation of medical devices - Part 5 Tests for In vitro cytotoxicity
| Standard | Test item | Test method | Criteria | Results |
|---|---|---|---|---|
| ISO 10993-5: | ||||
| 2009 | In Vitro | |||
| Cytotoxicity | In this study, mammalian L- 929 | |||
| cells were cultured in vitro | ||||
| according to ISO 10993- 5:2009 | ||||
| to test the potential cytotoxicity | ||||
| of the test article. The test | ||||
| articles and the control material | ||||
| were separately placed in MEM | ||||
| medium containing 10% fetal | ||||
| bovine serum, and extracted in a | ||||
| 37°C incubator for 24 hours. | ||||
| After the end of the extraction, | ||||
| the cell culture medium in the | ||||
| 96-well plate (104 cells/well) | ||||
| cultured for 24 hours was | ||||
| removed and replaced with the | ||||
| corresponding extract, cultured | ||||
| in 37°C, 5% | ||||
| CO2, >90% humidity for 24 | ||||
| hours. After the culture, the | ||||
| morphology and cell lysis of the | ||||
| cells were observed under the | ||||
| microscope, and the cytotoxicity | ||||
| of the test samples was | ||||
| determined by | ||||
| MTT assay. | The 50% extract of the test | |||
| article should have at least | ||||
| the same or a higher viability | ||||
| than the 100% extract. | ||||
| Otherwise the test should be | ||||
| repeated. | ||||
| The lower the Viab. % value, | ||||
| the higher the cytotoxic | ||||
| potential of the test article is. | ||||
| If viability is reduced to |