(252 days)
None
No
The device description and performance studies focus on the physical and biological properties of a medical glove, with no mention of AI or ML technologies.
No
Explanation: The device is described as a "patient examination glove" intended to "prevent contamination between patient and examiner," which classifies it as a barrier device, not a therapeutic one. Therapeutic devices are intended to treat or alleviate a condition.
No
Explanation: The device is a medical glove, described as a "disposable device intended for medical purposes that is worn on the examiner's hands or fingers to prevent contamination." Its testing focuses on physical and biological properties (e.g., freedom from holes, dimensions, toxicity), not on diagnosing a medical condition.
No
The device description clearly states it is a physical medical glove made from a nitrile latex compound, and the performance studies focus on physical and biological properties of the glove, not software functionality.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is a "powder free patient examination glove... worn on the examiner's hands or fingers to prevent contamination between patient and examiner." This is a barrier device used for protection, not for diagnosing a condition or analyzing a sample taken from the body.
- Device Description: The description focuses on the physical properties and materials of the glove, not on any diagnostic function.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a biological sample (blood, urine, tissue, etc.)
- Detecting specific analytes or markers
- Providing information for diagnosis, monitoring, or screening
- Performance Studies: The performance studies focus on the physical and biological properties of the glove (freedom from holes, dimensions, tensile strength, biocompatibility), which are relevant to its function as a barrier device, not as a diagnostic tool.
- Predicate Device: The predicate device is also a medical examination glove, further confirming the device's classification as a barrier device.
In summary, the device is a medical glove intended for barrier protection, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
A powder free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or fingers to prevent contamination between patient and examiner.
Product codes
LZA
Device Description
The proposed device is a powder free medical glove. The device is made from a nitrile latex compound, blue in color. The device meets the requirements of ASTM D6319-19: Standard specification for Nitrile Examination Gloves for Medical Application. The device is available in five sizes, which are XS, S, M, L, XL, it could be selected by the user depended on size of hand. The different between each size is just in the dimension. The device can be provided in non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands or fingers
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 tests were conducted to provide data that the proposed devices met the acceptance criteria or the specification for the test methodology or standard shown below. The test results demonstrated that the proposed devices comply with the following standards:
- A 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 D3767-03 Standard Practice for Rubber-Measurement of Dimensions
-
ASTM D412-16 Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers-Tension
- A ASTM D6124-06 (Reapproved 2017) Standard Test Method for Residual Powder on Medical Gloves
- A ISO 10993-10:2010 Biological Evaluation of Medical Devices-Part 10: Tests for Irritation and Skin Sensitization;
Test results:
- Freedom from Holes-ASTM D5151: No leakage
- Physical dimension-ASTM D6319: Length Larger than 220mm for XS and S size, Larger than 230mm for M, L and XL sizes. Width: XS: within 70±10mm, S: within 80±10mm, M: within 95±10mm, L: within 110±10mm, XL: within 120±10mm. Thickness: Larger than 0.05mm.
- Physical requirement-ASTM D412: Before aging Larger than 14Mpa and 500%. After aging Larger than 14Mpa and 400%.
- Powder residue-ASTM D6214: Less than 2.0mg.
- Skin sensitization-ISO 10993-10: No skin sensitization.
- Skin irritation-ISO 10993-10: No skin irritation.
- Acute toxicity-ISO 10993-11: No acute toxicity.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
August 20, 2021
Beijing Biosis Healing Biological Technology Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai. 200120 China
Re: K203622
Trade/Device Name: Medical Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: July 10, 2021 Received: July 19, 2021
Dear Diana Hong:
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,
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 Quality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K203622
Device Name Medical Gloves
Indications for Use (Describe)
A powder free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or fingers 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
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
The assigned 510(k) Number: K203622
-
- Date of Preparation: 08/19/2021
-
- Sponsor Identification
Beijing Biosis Healing Biological Technology Co., Ltd. No.6 Plant West, Valley No.1 bio-medicine Industry Park, Daxing District, Beijing, 102600, China.
Establishment Registration Number: 3016668451
Contact Person: Ting Jiang Position: RA Director Tel: +86-10-61252660 Fax: +86-10-61252030 Email: Jiangting@biosishealing.com
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Ying Xu (Alternative Contact Person)
- Designated Submission Correspondent
Mid-Link Consulting Co., Ltd. P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850, Fax: 360-925-3199 Email: info@mid-link.net
4
K203622
- Identification of Proposed Device 4.
Trade Name: Medical Gloves Common Name: Patient Examination Glove
Regulatory Information Classification Name: Non-powderedpatient examination glove Classification: I; Product Code: LZA Regulation Number: 21 CFR 880.6250 Review Panel: General Hospital
Indication for use:
A powder free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or fingers to prevent contamination between patient and examiner.
Device Description:
The proposed device is a powder free medical glove. The device is made from a nitrile latex compound, blue in color. The device meets the requirements of ASTM D6319-19: Standard specification for Nitrile Examination Gloves for Medical Application. The device is available in five sizes, which are XS, S, M, L, XL, it could be selected by the user depended on size of hand. The different between each size is just in the dimension. The device can be provided in non-sterile.
- ર. Identification of Predicate Device
510(k) Number: K180467 Product Name: SBG Blue Nitrile Powder Free Medical Examination Glove
5
-
- Technological Comparison:
| ITEM | Proposed Device | Predicate Device | Remark |
|---|---|---|---|
| Product Code | K203622 | K180467 | Same |
| Regulation | |||
| Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Class | Class I | Class I | Same |
| Indication for use | A powder free patient examination | ||
| glove is a disposable device | |||
| intended for medical purposes that | |||
| is worn on the examiner's hands or | |||
| fingers to prevent contamination | |||
| between patient and examiner. | A powder free patient | ||
| examination glove is a disposable | |||
| device intended for medical | |||
| purposes that is worn on the | |||
| examiner's hands or fingers to | |||
| prevent contamination between | |||
| patient and examiner. | Same | ||
| Material | Nitrile latex compound | Nitrile latex compound | Same |
| Color | Blue | Blue | Same |
| Sterility | Non-sterile | Non-sterile | Same |
| Model | XS, S, M, L, XL | S, M, L, XL | Analysis 1 |
| Dimensions | |||
| (ASTM D6319-19) | > 220 mm (XS and S sizes) |
230 mm (M, L and XL sizes)
Width(±10mm)
XS = 70mm
S = 80mm
M = 95mm
L = 110mm
XL = 120mm
Thickness at Finger (mm)
All Sizes ≥ 0.05 mm
Thickness at Palm
All Sizes ≥ 0.05 mm | Overall Length (mm)
220 mm = (sizes XS-S)
230 mm = (sizes M-XL)
Width (± 10 mm)
Size S = 80 mm
Size M = 95 mm
Size L = 110 mm
Size XL = 120 mm
Thickness at Finger (mm)
All Sizes = 0.05 mm
Thickness at Palm
All Sizes = 0.05 mm | Analysis 2 |
| Physical Properties
(ASTM D6319-19
and
ASTM
D412-16) | Before Aging
Tensile Strength ≥ 14Mpa
Ultimate Elongation ≥ 500%
After Aging
Tensile Strength ≥ 14Mpa
Ultimate Elongation ≥ 400% | Before Aging
Tensile Strength ≥ 14Mpa
Ultimate Elongation ≥ 500%
After Aging
Tensile Strength ≥ 14Mpa
Ultimate Elongation ≥ 400% | Analysis 3 |
| Powder free residue
(ASTM D6319-19 and ASTM D6124-06) | Less than 2 mg per glove | Less than 2 mg per glove | Analysis 4 |
| Freedom from Holes
(ASTM D5151-19) | AQL 2.5 Inspection
Level G-1
Accept at 5 failures
Reject at 6 failures
Meets ASTM D5151-19 | AQL 2.5 Inspection
Level G-1
Accept at 5 failures
Reject at 6 failures
Meets ASTM D5151-06 | Analysis 5 |
| Skin Irritation | No Irritation | No Irritation | Same |
| Sensitization | No Sensitization | No Sensitization | Same |
| Acute toxicity | No acute toxicity | / | Analysis 6 |
Table 1 General
Technological Comparison
6
Analysis 1 - Model
The proposed device has the additional XS size compared to predicate device. A various sizes could provide more choices for users and the different size does not affect intended use. In addition, the size XS of proposed device has been tested and the test result demonstrated that it could meet the requirements of ASTM D6319-19. Therefore, it can be considered that this difference does not affect substantially equivalence on safety and effectiveness.
Analysis 2 - Dimensions
The dimensions of proposed device are different from predicate device 1. The proposed device has one more XS size and the minimum length of proposed device is larger than the predicate device 1. In addition, the proposed device was tested according to the ASTM D6319-19 while the predicate device 1 was tested according to ASTM D6319-10. However, these two standards are just different in version and all test results of dimensions for proposed device could met the requirements of ASTM D6319 -19. Therefore, it can be considered that this difference does not affect substantially equivalence on safety and effectiveness.
Analysis 3 - Physical Properties
The standard version of Physical Properties requirements for the proposed device is different from the predicated device 1. The proposed device was tested and met the requirements of ASTM D6319 -19 while the predicate device 1 was tested and met the requirements of ASTM D6319-10. However, these two standards are just different in version. Therefore, it can be considered that this difference does not affect substantially equivalence on safety and effectiveness.
7
Analysis 4 - Powder free residue
The standard version of Powder free residue requirements for the proposed device is different from the predicated device 1. The proposed device was tested and met the requirements of ASTM D6319 -19 while the predicate device 1 was tested and met the requirements of ASTM D6319-10. However, these two standards are just different in version. Therefore, it can be considered that this difference does not affect substantially equivalence on safety and effectiveness.
Analysis 5 - Freedom from Holes
The standard version of Freedom from Holes requirements for the proposed device is different from the predicated device 1. The proposed device was tested and met the requirements of ASTM D5151 -19 while the predicate device 1 was tested and met the requirements of ASTM D5151-06. However, these two standards are just different in version. Therefore, it can be considered that this difference does not affect substantially equivalence on safety and effectiveness.
Analysis 6-Biocompabitlity
The contact level and duration for the proposed device is intact skin and limited contact. Cytotoxicity, Skin sensitization and irritation shall be evaluated for the proposed device per FDA guidance. Acute toxicity test was evaluated for the proposed device instead of cytotoxicity. The test result showed that there was no adverse effect. Therefore, it can be considered that the proposed device is safety as the predicate device.
7. Non-Clinical Testing:
Non clinical tests were conducted to provide data that the proposed devices met the acceptance criteria or the specification for the test methodology or standard shown below. The test results demonstrated that the proposed devices comply with the following standards:
- A 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 D3767-03 Standard Practice for Rubber-Measurement of Dimensions
-
ASTM D412-16 Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers-Tension
- A ASTM D6124-06 (Reapproved 2017) Standard Test Method for Residual Powder on Medical Gloves
- A ISO 10993-10:2010 Biological Evaluation of Medical Devices-Part 10: Tests for Irritation and Skin Sensitization;
8
| Test Method | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| Freedom from Holes-ASTM | |||
| D5151 | Detection the holes that | ||
| allow water leakage | Do not show droplet, stream | ||
| or other type of water | |||
| leakage | No leakage | ||
| Physical dimension-ASTM | |||
| D6319 | Evaluate the glove | ||
| physical dimension | Length: >220 mm (XS and | ||
| S sizes) | |||
| Length: > | |||
| 230 mm | |||
| (M, L and XL sizes) | |||
| Width (±10mm) | |||
| XS = 70mm | |||
| S = 80mm | |||
| M = 95mm | |||
| L = 110mm | |||
| XL = 120mm | |||
| Thickness at Finger (mm) | |||
| All Sizes ≥ 0.05 mm | |||
| Thickness at Palm | |||
| All Sizes ≥ 0.05 mm | Length | ||
| Larger than 220mm for | |||
| XS and S size | |||
| Larger than 230mm for | |||
| M, L and XL sizes | |||
| Width | |||
| XS: within 70±10mm | |||
| S: within 80±10mm | |||
| M: within 95±10mm | |||
| L: within 110±10mm | |||
| XL: within 120±10mm | |||
| Thickness | |||
| Larger than 0.05mm | |||
| Physical requirement-ASTM | |||
| D412 | Evaluate the physical | ||
| requirement | Before Aging (Min) | ||
| Tensile strength: 14Mpa | |||
| Ultimate elongation: 500% | |||
| After Aging (Min) | |||
| Tensile strength: 14Mpa | |||
| Ultimate elongation: 400% | Before aging | ||
| Larger than 14Mpa and | |||
| 500% | |||
| After aging | |||
| Larger than 14Mpa and | |||
| 400% | |||
| Powder residue-ASTM D6214 | Evaluate the residue | ||
| powder | Less than 2.0mg | Less than 2.0mg | |
| Skin sensitization-ISO 10993- | |||
| 10 | Evaluated for the potential | ||
| to cause delayed dermal | |||
| contact sensitization | Magnusson and Kligman | ||
| grade shall be less than | |||
| control group | No skin sensitization | ||
| Skin irritation-ISO 10993-10 | Evaluated for the potential | ||
| to cause skin irritation | No significant reaction than | ||
| the control group | No skin irritation | ||
| Acute toxicity-ISO 10993-11 | Evaluated for acute | ||
| systemic toxicity | No significant reaction than | ||
| the control group | |||
| Animal death or abnormal | |||
| behaviour no more than two | |||
| animals | |||
| Body weight loss greater | |||
| than 10% no more than 3 | |||
| animals | No acute toxicity |
9
8. Conclusion
The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(k) submission K203622, the Medical Gloves, is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K180467.