(219 days)
Not Found
No
The device description and performance studies focus on the physical properties and biocompatibility of examination gloves, with no mention of AI or ML.
No
The device, Powder Free Nitrile Patient Examination Gloves, is intended to prevent contamination and is not designed to treat or cure a disease or condition.
No
Explanation: The device is described as a non-sterile disposable glove intended to prevent contamination between a patient and examiner, not to diagnose a condition.
No
The device is a physical glove made of nitrile butadiene rubber, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used outside of the body.
- Device's Intended Use: The intended use of these gloves is to be worn on the examiner's hand or finger to prevent contamination between the patient and the examiner. This is a barrier function, not a diagnostic function performed on a specimen.
- Device Description: The description clearly states it's a "medical glove intended for medical purposes that is worn on the examiner's hand or finger".
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances, or providing diagnostic information.
The device described is a Class I medical device (specifically, a patient examination glove) used for barrier protection during medical examinations.
N/A
Intended Use / Indications for Use
Powder Free Nitrile Patient Examination Gloves, Blue Color is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Product codes (comma separated list FDA assigned to the subject device)
LZA
Device Description
The proposed device is Powder Free Nitrile Examination Gloves. The proposed device is non-sterile and disposable medical glove intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
The proposed device is made of nitrile butadiene rubber (NBR), as per standard meets ASTM D6319-10(Reapproved 2015).
The proposed device is Powder Free Nitrile Examination and variants of different sizes, such as size S/M/L/XL. All variants share the same color, blue.
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 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)
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:
- ASTM D 6319-06 (Reapproved 2015) for Dimension, Physical Properties (Tensile strength, Elongation)
- 21 CFR 800.20, ASTM D 6319-06 (Reapproved 2015), ASTM D5151-19 for Freedom from pinholes (Water leakage test)
- ASTM D6319-10 (Reapproved 2015), ASTM D6124-06 (Reapproved 2017) for Powder Residual
- Primary Skin Irritation in rabbits ISO 10993-10: 2010-08-01 for Biocompatibility (Primary Skin Irritation)
- Dermal sensitization in the guinea pig ISO 10993-10:2010-08-01 for Biocompatibility (Dermal sensitization)
- The test article was added to L929 cells measured by MTT assay ISO 10993-5:2009 for Biocompatibility (Cytotoxicity)
- Acute Systemic Toxicity Systemic injection in mice ISO 10993-11:2017 for Biocompatibility (Acute Systemic Toxicity)
Key Results:
- Dimension: Length ≥ 230mm min (Result: 237 mm min for all sizes); Width Small 70-90 mm (Result: 85-87 mm), Medium 85-105mm (Result: 95-97 mm), Large 100-120mm (Result: 105-107mm); Thickness Fingertip ≥ 0.05 mm (Result: 0.091mm), Palm (Result: 0.072mm)
- Physical Properties: Tensile strength (Before & After aging) ≥14MPa (Result: 16.5-19.3 MPa); Before aging Elongation ≥500% (Result: 526-560%); After aging Elongation ≥400% (Result: 432-492%)
- Freedom from pinholes: Water leakage test: Inspection Level I, AQL2.5, and Accept/Reject criteria of 10/11 (Result: 2 noncompliance is allowed. Pass)
- Powder Residual: Meets
§ 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 on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
January 21, 2022
Siyang Jaysun Medtech Co., Ltd. % Chu Xiaoan Official Correspondent Beijing Easy-Link Company Rm. F302 Bldg., 41, Jing Cheng Ya Ju, Courtyard 6 of Southern Dou Ge Zhuang,Chaoyang District Beijing, 100121 China
Re: K211864
Trade/Device Name: Powder Free Nitrile Patient Examination Gloves, Blue Color Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: December 16, 2021 Received: December 20, 2021
Dear Chu Xiaoan:
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.
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
Indications for Use
510(k) Number (if known) K211864
Device Name
Powder Free Nitrile Patient Examination Gloves, Blue Color
Indications for Use (Describe)
Powder Free Nitrile Patient Examination Gloves, Blue Color is a non-sterile disposable device intended for medical purposes 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)
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3
510(K) Summary
K211864
This summary of 510(k) is being submitted in accordance with 21 CFR 807.
Premarket Notification [510(k)] Summary
1.0 Submitter:
| Submitter's name : | Siyang Jaysun Medtech Co., Ltd. |
|---|---|
| Submitter's address : | No.26 Changjiang Rd, Siyang Economic |
| Development Zone, Suqian City, Jiangsu | |
| Province,223700,China | |
| Name of contact person: | Mr. Chen Fang |
| Contact phone number | 0086-0527- 85552002 |
| Date of preparation : | 2022-01-17 |
2.0 Name of the Device
| Proprietary/Trade name: | Powder Free Nitrile Patient Examination
Gloves, Blue Color |
|-------------------------|---------------------------------------------------------------|
| Common Name: | Patient Examination gloves |
| Classification Name: | Non-powdered Patient examination glove |
| Device Classification: | I |
| Regulation Number: | 21 CFR 880.6250 |
| Panel: | General Hospital |
| Product Code: | LZA |
3.0 Predicate device
| Device Name: | Powder Free Nitrile Patient Examination
Glove, Blue Color |
|----------------|--------------------------------------------------------------|
| Company name: | Tangshan Zhonghong Pulin Plastic Co., Ltd. |
| 510(K) Number: | K120970 |
4.0 Device Description:
The proposed device is Powder Free Nitrile Examination Gloves. The proposed device is non-sterile and disposable medical glove intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
The proposed device is made of nitrile butadiene rubber (NBR), as per standard meets ASTM D6319-10(Reapproved 2015).
The proposed device is Powder Free Nitrile Examination and variants of different sizes, such as size S/M/L/XL. All variants share the same color, blue.
4
5.0 Indications for Use Statement:
Powder Free Nitrile Patient Examination Gloves, Blue Color is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
| Features & Description | Predicate Device (K120970) | Subject Device (K211864) | Result of Comparison |
|---|---|---|---|
| Product name | Powder Free Nitrile Patient Examination Glove, Blue Color | Powder Free Nitrile Patient Examination Gloves, Blue Color | Same |
| Regulation Number | 21CFR880.6250 | 21CFR880.6250 | Same |
| Product Code | LZA | LZA | Same |
| Color | Blue | Blue | Same |
| Size | Small/ Medium/ Large/X large | Small/ Medium/ Large/X large | Same |
| Indications for Use | Powder Free Nitrile Patient 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. | Powder Free Nitrile Patient Examination Gloves, 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. | Same |
| Dimensions --Length | |||
| Inspection Level S-2 | |||
| AQL4.0 | Meets ASTM D6319-10 | ||
| ≥230mm min | 237 mm min for all sizes | Similar | |
| Dimensions -- Width | |||
| Inspection Level S-2 | |||
| AQL4.0 | Meets ASTM D6319-10 | ||
| Small 70-90 mm | |||
| Medium 85-105mm | |||
| Large 100-120mm | |||
| X large 110-130 mm | Small 85-87mm | ||
| Medium 95-97 mm | |||
| Large 105-107mm | |||
| X large 115-117 mm | Similar | ||
| Dimensions --Thickness | |||
| Inspection Level S-2 | |||
| AQL4.0 | Meets ASTM D6319-10 | ||
| Finger 0.05mm min. | |||
| Palm 0.05mm min. | Thickness (mm) min. | ||
| Finger 0.091 | |||
| Palm 0.072 | Similar | ||
| Physical Properties | |||
| Inspection Level S-2 | |||
| AQL4.0 | Meets ASTM D D6319-10 | ||
| Before aging/after aging | |||
| Tensile Strength≥ 14MPa | |||
| Before aging | |||
| Elongation ≥500% | |||
| After aging | |||
| Elongation ≥400% | Aging Before After | ||
| Elongation (%) 526-560 432-492 | |||
| Tensile Strength (MPa) 17.5-19.3 16.5-18.5 | Similar | ||
| Freedom from Pinholes | |||
| Inspection Level I | |||
| AQL2.5 | Meets | ||
| • 21 CFR 800.20 | |||
| • ASTM D6319-10 | 1) Inspection Level I AQL2.5,and Accept/Reject criteria of 10/11 |
- Water leakage test: 2 noncompliance is allowed. | Similar |
| | D 6124-06
(Reaffirmation 2011) | sub-samples (N=5). - Result as following:
Mean: 0.6-0.9 mg/pcs | |
| | below 2mg of residual
powder | | |
| Materials used to
fabricate the devices | Nitrile | Nitrile | Same |
| Single Use | Single Use | Single Use | Same |
| Biocompatibility
Primary Skin
Irritation-ISO
10993-10:2010(E) | Under the condition
of study, not an
irritant | Under the condition
of study, not an
irritant | Same |
| Biocompatibility
Dermal
Sensitization-ISO
10993-10:2010(E) | Under the conditions
of the study, not a
sensitizer | Under the conditions
of the study, not a sensitizer. | Same |
| Biocompatibility
In vitro
cytotoxicity
ISO10993-5
:2009(E) | N.A. | Under the conditions of this
study, the test article was
shown potential toxicity to
L-929 cells | Different |
| Biocompatibility
Acute Systemic
Toxicity Systemic
injection in mice
ISO 10993-11:2017 | N.A. | Under the conditions of
study, the device extracts do
not pose a systemic toxicity
concern (ISO
10993-11:2017) | Different |
| Labeling for the
legally marketed
device to which
substantial
equivalence is
claimed. | -Powder Free
-Patient Examination
Glove
-Single Use Only
- Manufactured For:
- Lot
-Blue color - Non sterile | -Powder Free
-Patient Examination Glove
-Single Use Only - Manufactured For:
- Lot
-Blue color - Non sterile | Same |
Technological Characteristic Comparison: 6.0
5
For all above differences (state "similar" in the right column on above table) between the subject and predicate devices, they are derived from both individual product differentiation and each items are within the range, complied with all requirements of the standards at the current time, so those differences are not critical to the intended use and the differences do not affect the safety and effectiveness of the subject device.
7.0 Discussion of Non-clinical and Performance 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:
| Test Method | Purpose | Acceptance Criteria | Results | |
|---|---|---|---|---|
| ASTM D 6319-06 | ||||
| (Reapproved 2015). | Dimension | Length | $\geq$ 230mm | 237 mm min for all sizes |
| Width | Small 70-90 mm | 85-87 mm | ||
| Medium 85-105mm | 95-97 mm | |||
| Large 100-120mm | 105-107mm | |||
| Thickness | Fingertip $\geq$ 0.05 mm | 0.091mm |
6
| Palm | 0.072mm | |||||
|---|---|---|---|---|---|---|
| ASTM D 6319-06 | ||||||
| (Reapproved 2015). | Physical | |||||
| Properties | Tensile | |||||
| strength | ||||||
| (Before & | ||||||
| After aging) | ≥14MPa | 16.5-19.3 MPa | ||||
| Before | ||||||
| aging | ||||||
| Elongation | ≥500% | 526-560% | ||||
| After aging | ||||||
| Elongation | ≥400% | 432-492% | ||||
| •21 CFR 800.20 | ||||||
| • ASTM D 6319-06 | ||||||
| (Reapproved 2015). | ||||||
| • ASTM D5151-19 | Freedom | |||||
| from | ||||||
| pinholes | Water leakage test: | |||||
| Inspection LevelI, AQL2.5, and | ||||||
| Accept/Reject criteria of 10/11. | 2 | |||||
| noncompliance | ||||||
| is allowed. | ||||||
| Pass | ||||||
| • ASTM | ||||||
| D6319-10(Reappr | ||||||
| oved 2015) | ||||||
| • ASTM D6124-06 | ||||||
| (Reapproved | ||||||
| 2017), | Powder | |||||
| Residual | Meets |