(89 days)
Not Found
No
The 510(k) summary describes standard medical examination gloves and does not mention any AI or ML components or functionalities.
No
The device, examination gloves, is intended to prevent contamination, not to treat or diagnose a disease or condition.
No
The device is described as medical examination gloves intended to prevent contamination, not to diagnose any condition or disease.
No
The device is a physical medical device (gloves) and does not involve any software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for medical purposes that is worn on the examiners hands to prevent contamination between patient and examiner." This describes a barrier device used for protection, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description focuses on the physical characteristics and standards related to gloves (powder content, freedom from holes, physical dimensions, physical properties). This aligns with a medical device used for protection, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, calibrators, controls, or any other components typically associated with in vitro diagnostics.
- Performance Studies: The performance studies listed (Cytotoxicity, Irritation, Sensitization, Systemic toxicity, Powder Content, Freedom from Holes, Physical Dimensions Test, and Physical properties) are relevant to the safety and performance of a medical glove, not an IVD.
Therefore, this device falls under the category of a medical device, specifically a medical glove, and not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Disposable Vinyl/Nitrile Blend Medical Examination Gloves is intended for medical purposes that is worn on the examiners hands 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 powder free vinyl patient examination gloves. The subject device is blue. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The subject device is non-sterile.
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 / 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)
The following performance data has been provided to demonstrate that the subject device meets the acceptance criteria in the standard.
Study type: Non-Clinical Performance Testing
Tests conducted:
- ISO 10993-5 (Cytotoxicity): Under conditions of the study, did not show potential toxicity to L-929 cells.
- ISO 10993-10 (Irritation): Under the conditions of the study, not an irritant. Pass.
- ISO 10993-10 (Sensitization): Under conditions of the study, not a sensitizer. Pass.
- ISO 10993-11 (Systemic toxicity): Under the conditions of the study, the device does not elicit a systemic toxicity response in the model animal. Pass.
- ASTM D6124-06 (Powder Content): 0.15mg -0.18 mg /glove, meeting the powder residue limit of 2.0 mg.
- ASTM D5151-06 (Reapproved 2015) (Freedom from Holes): Samples number: 125 gloves. AQL: 2.5 (ISO 2859). Criterion ≤7 gloves for water leakage. Results: no glove water leakage found.
- ASTM D5250 (Physical Dimensions Test):
- Lot no. 1: S: width: 83-88 mm, Length 231-238 mm (one data 227mm, the number of non-conforming is 1, acceptable); M: width 92-96 mm, Length 233-236 mm; L: width 102-106 mm, Length 246-253 mm; XL: width 111-116 mm, Length 242-245 mm. Thickness: Finger 0.10-0.11 mm, Palm 0.07-0.08 mm.
- Lot no. 2: S: width: 82-85 mm, Length 232-235 mm; M: width 92-96 mm, Length 232-236 mm; L: width 103-106 mm, Length 243-249 mm; XL: width 111-116 mm, Length 237-243 mm. Thickness: Finger 0.11-0.12 mm, Palm 0.07-0.08 mm.
- Lot no. 3: S: width: 82-87 mm; M: width 93-96mm, Length 230-239 mm; L: width 103-107mm, Length 243-249 mm; XL: width 112-116 mm, Length 244-249 mm. Thickness: Finger 0.11 mm, Palm 0.07-0.08 mm. All Pass.
- ASTM D412 (Physical properties)
- Before Aging: Tensile Strength: Lot 1: 12.7-24 MPa, Lot 2: 15.1-25.1 MPa, Lot 3: 14.5-23.5 MPa (all Pass, acceptance ≥11MPa); Ultimate Elongation: Lot 1: 300.08-397.467 %, Lot 2: 300.547-380.29 % (one data 228.080, the number of non-conforming is 1, acceptable), Lot 3: 303.365-389.716 % (all Pass, acceptance ≥300%).
- After Aging: Tensile Strength: Lot 1: 14.2-22.4 MPa, Lot 2: 16.0-23.8 MPa, Lot 3: 14.4-23.3 MPa (all Pass, acceptance ≥11MPa); Ultimate Elongation: Lot 1: 301.276-394.245 %, Lot 2: 300.79-399.170 %, Lot 3: 307.674-399.758 % (all Pass, acceptance ≥300%).
No clinical study is included in this submission.
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 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 square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 11, 2021
Bytech(Dongtai) Co., Ltd. Boyle Wang Manager Shanghai Truthful information Technology Co., Ltd. Room608,No.738,Shangcheng Rd.,Pudong Shanghai, Shanghai 200120 China
Re: K212899
Trade/Device Name: Disposable Vinyl/Nitrile Blend Medical Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LYZ Dated: August 30, 2021 Received: September 13, 2021
Dear Boyle 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 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, 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
510(k) Number (if known) K212899
Device Name
Disposable Vinyl/Nitrile Blend Medical Examination Gloves
Indications for Use (Describe)
The Disposable Vinyl/Nitrile Blend Medical Examination Gloves is intended for medical purposes that is worn on the examiners 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)
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3
K212899 510(k) Summary
This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.
1.0 Submitter's Information
Name: Bytech (Dongtai) Co., Ltd. Address: XinYuan Industrial Park,TangYang Town, DongTai City, Jiangsu Province, China Phone Number: Contact: Mr. Wang Cheng Date of Preparation: 2021.08.30
Designated Submission Correspondent
Mr. Boyle Wanq Shanghai Truthful Information Technology Co., Ltd. Room 608, No. 738 Shangcheng Rd., Pudong Shanghai, 200120 China Tel: +86-21-50313932 Email: Info@truthful.com.cn
2.0 Device information
Trade name: Disposable Vinyl/Nitrile Blend Medical Examination Gloves Common name: Disposable Vinyl/Nitrile Blend Medical Examination Gloves Classification name: Non-powdered Patient Examination Glove Model(s): S, M, L, XL
3.0 Classification
Production code: LYZ Regulation number: 21CFR880.6250 Classification: Class I Panel: General Hospital
4.0 Predicate device information
Tangshan Hongyun Healthcare Products Co.,Ltd. Manufacturer: Device: Disposable Vinyl Nitrile Synthetic Gloves Powder Free 510(k) number: K211262
4
5.0 Indication for Use
The Disposable Vinyl/Nitrile Blend Medical Examination Gloves is intended for medical purposes that is worn on the examiners hands to prevent contamination between patient and examiner.
6.0 Device description
The subject device is powder free vinyl patient examination gloves. The subject device is blue. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The subject device is non-sterile.
7.0 Summary comparing technological characteristics with predicate device
| Item | Subject device | Predicated device | Comparison |
|---|---|---|---|
| 510(k) number | K212899 | K211262 | / |
| Product Code | LYZ | LYZ | Same |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same |
| Class | I | I | Same |
| Intended Use | The Disposable | ||
| Vinyl/Nitrile Blend | |||
| Medical Examination | |||
| Gloves is a disposable | |||
| device intended for | |||
| medical purposes that is | |||
| worn on the examiner's | |||
| hands to prevent | |||
| contamination between | |||
| patient and examiner. | The Disposable Vinyl | ||
| Nitrile Synthetic Gloves | |||
| Powder Free is a | |||
| disposable device | |||
| intended for medical | |||
| purposes that is worn | |||
| on the examiner's | |||
| hands to prevent | |||
| contamination between | |||
| patient and examiner. | Same | ||
| Powdered or Powered free | Powdered free | Powdered free | Same |
| Design Feature | ambidextrous | ambidextrous | Same |
| Labeling Information | Single use, powder free, | ||
| device color, device | |||
| name, glove size and | |||
| quantity, Vinyl | |||
| Examination Gloves, | |||
| Non-Sterile | Single use, powder | ||
| free, device color, | |||
| device name, glove size | |||
| and quantity, Vinyl | |||
| Examination Gloves, | |||
| Non-Sterile | Same |
Table1-General Comparison
Table2 Device Dimensions Comparison
| Predicate | Designation | Size | Tolerance |
|---|---|---|---|
5
| Device(K211262) | S | M | L | XL | ||
|---|---|---|---|---|---|---|
| Length, mm | 230 | 230 | 230 | 230 | min | |
| Width, mm | 85 | 95 | 105 | 115 | $\pm$ 5 | |
| Thickness, mm: | ||||||
| Finger | 0.05 | min | ||||
| Palm | 0.05 | min | ||||
| Subject Device | Designation | Size | Tolerance | |||
| S | M | L | XL | |||
| Length, mm | 230 | 230 | 230 | 230 | min | |
| Width, mm | 85 | 95 | 105 | 115 | $\pm$ 5 | |
| Thickness, mm: | ||||||
| Finger | 0.05 | min | ||||
| Palm | 0.05 | min | ||||
| Remark | Same |
Table3 Performance Comparison
| Item | Subject device | Predicated device | Comparison | ||
|---|---|---|---|---|---|
| Colorant | Blue | Blue | SAME | ||
| Physical | |||||
| Properties | Before Aging | Tensile | |||
| Strength | SAME | 11MPa, min | SAME | ||
| Ultimate | |||||
| Elongation | SAME | 300%min | SAME | ||
| After | |||||
| Aging | Tensile | ||||
| Strength | SAME | 11MPa, min | SAME | ||
| Ultimate | |||||
| Elongation | SAME | 300%min | SAME | ||
| Comply with ASTM D5250 | Comply with ASTM D5250 | SAME | |||
| Freedom from Holes | Be free from holes when tested in accordance with ASTM D5151 AQL=2.5 | Be free from holes when tested in accordance with ASTM D5151 AQL=2.5 | SAME | ||
| Powder Content | 0.15-0.18 mg per glove | 0.07 mg per glove. Meet the requirements of ASTM D6124 | SIMILAR |
Analysis: The powder content is different with that of the predicate, but they all meet the requirements of ASTM D5250 ASTM D6124 - 06(2017).
Table4 Safety Comparison
| Item | Subject device | Predicated device | Comparison |
|---|---|---|---|
| Material | Vinyl | Vinyl | SAME |
| Biocompatibility | Irritation | ||
| Under the conditions of the study, not an irritant | Comply with | ||
| ISO10993-10 | SAME |
6
| Sensitization | Under conditions of the study, not a sensitizer. | |||
|---|---|---|---|---|
| Cytotoxicity | Under the conditions of the study, the device is potentially cytotoxic | Comply with ISO10993-5 | SIMILAR | |
| Systemic toxicity | Under the conditions of the study, the device does not elicit a systemic toxicity response in the model animal. | Complies with ISO 10993-11 Third edition 2017-09 | ||
| Label and Labeling | Meet FDA's Requirement | Meet FDA's Requirement | SAME |
Analysis: The material of subject device are different with that of the predicate device, but biocompatibility test has been performed on subject device and the test result can meet the requirements of ISO 10993 standards.
8.0 Summary of Non-Clinical Performance Testing
The following performance data has been provided to demonstrate that the subject device meets the acceptance criteria in the standard.
| Table 5 Summary of Non-Clinical Performance Testing | |
|---|---|
| ----------------------------------------------------- | -- |
| No. | Name of the Test
Methodology / Standard | Purpose | Acceptance Criteria | Results |
|-----|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | ISO 10993-5 | Cytotoxicity | Non-cytotoxic | Under conditions of the study, did
not show potential toxicity to
L-929 cells. |
| 2 | ISO 10993-10 | Irritation | Non-irritating | Under the conditions of the study,
not an irritant. Pass |
| 3 | ISO 10993-10 | Sensitization | Non-sensitizing | Under conditions of the study, not
a sensitizer. Pass |
| 4 | ISO 10993-11 | Systemic toxicity | Non-Systemic toxic | Under the conditions of the study,
the device does not elicit a
systemic toxicity response in the
model animal. Pass |
| 5 | ASTM D6124-06 | This standard is
designed to
determine the
amount ofresidual
powder (or
filter-retained
mass) found | powder residue limit of
2.0 mg | 0.15mg -0.18 mg /glove |
| | | | | |
| 6 | ASTM
D5151-06(Reapproved2
015) | on medical gloves
This test method
covers the
detection of holes
in
medical gloves. | Samples number: 125 gloves
AQL: 2.5 (ISO 2859)
Criterion ≤7 gloves
for water leakage | no glove water leakage found |
| 7 | ASTM D5250 | Physical
Dimensions Test | Sterility: no need
Freedom from holes:
pl. Refer to No. 5 in
table 5
Dimensions:
Length(mm):≥230;
Width(mm):
S: 85±5;
M: 95±5;
L: 105±5;
XL: 115±5;
Thickness (mm):
Finger: ≥0.05 Palm:
≥0.05 | N.A.
Please refer to No. 5 in table 5
Lot no. 1:
Dimensions:
S: width: 83-88 mm
Length 231-238 mm (one data
227mm, the number of
non-conforming is 1, acceptable)
M: width 92-96 mm
Length 233-236 mm
L: width 102-106 mm
Length 246-253 mm
XL: width 111-116 mm
Length 242-245 mm
Thickness:
Finger 0.10-0.11 mm
Palm 0.07-0.08 mm
Lot no.:2
Dimensions:
S: width: 82-85 mm
Length 232-235 mm
M: width 92-96 mm
Length 232-236 mm
L: width 103-106 mm
Length 243-249 mm
XL: width 111-116 mm
Length 237-243 mm
Thickness:
Finger 0.11-0.12 mm
Palm 0.07-0.08 mm
Lot no.:3
Dimensions:
S: width: 82-87 mm |
7
8
| | | | | | | M: width 93-96mm
Length 230-239 mm |
|---|-----------|---------------------|----------------|------------------------|------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | | | | L: width 103-107mm
Length 243-249 mm |
| | | | | | | XL: width 112-116 mm
Length 244-249 mm |
| | | | | | | Thickness: |
| | | | | | | Finger 0.11 mm |
| | | | | | | Palm 0.07-0.08 mm |
| | | | | | | Pass |
| 8 | ASTM D412 | Physical properties | Befor
Aging | Tensile
Strength | ≥
11MPa | Lot 1: 12.7-24 MPa
Lot 2: 15.1-25.1 MPa
Lot 3: 14.5-23.5 MPa
Pass |
| | | | | Ultimate
Elongation | ≥
300% | Lot 1: 300.08-397.467 %
Lot 2: 300.547-380.29 %
(one data 228.080, the number
of non-conforming is 1,
acceptable)
Lot 3: 303.365-389.716 %
Pass |
| | | | After
Aging | Tensile
Strength | ≥
11MPa | Lot 1: 14.2-22.4 MPa
Lot 2: 16.0-23.8 MPa
Lot 3: 14.4-23.3 MPa
Pass |
| | | | | Ultimate
Elongation | ≥
300% | Lot 1: 301.276-394.245 %
Lot 2: 300.79-399.170 %
Lot 3: 307.674-399.758 %
Pass |
9. Summary of Clinical Performance Test
No clinical study is included in this submission.
10.0 Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicated device.