(136 days)
(K) 040841, (K) 022765
Not Found
No
The device is a disposable examination glove, and the description and testing focus on material properties and barrier function, with no mention of AI or ML.
No.
The device is a patient examination glove, intended to prevent contamination between patient and examiner, not to treat a condition.
No
This device is a patient examination glove, intended to prevent contamination between patient and examiner. It does not perform any diagnostic function.
No
The device description clearly states it is a physical glove made of nitrile, not software.
Based on the provided information, 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... intended for medical purposes that is worn on the examiners hand or finger to prevent contamination between patient and examiner." This describes a barrier device used for protection during physical examination, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description reinforces that it's a "disposable device powdered with absorbable dusting powder that meets all requirements of ASTM D 631900a-05 and is tested with chemotherapy drugs." This further describes a physical barrier device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, calibrators, controls, or any other components typically associated with in vitro diagnostic testing.
In summary, the device is a medical glove used as a physical barrier, which falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
A powder free patient examination glove (Tested for Use with Chemotherapy Drugs) is a disposable device intended for medical purposes that is worn on the examiners hand or finger to prevent contamination between patient and examiner. These gloves are not intended to be used as a chemical barrier.
Product codes (comma separated list FDA assigned to the subject device)
LZA
Device Description
Shanghai China Star Corp Powder free blue Nitrile Examination Glove is a class I device having product code 80LZA. It is a disposable device powdered with absorbable dusting powder that meets all requirements of ASTM D 631900a-05 and is tested with chemotherapy drugs.
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)
The standards used by Shanghai Chinstar Corp to determine substantial equivalence are based on ASTM D 631900a-2005. All testing meets requirements for physical specifications and dimensions conducted on gloves, Inspection level S-2, AQL 4.0, pinholes at AQL 2.5
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.
(K) 040841, (K) 022765
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
SHANGHAI CHINASTAR COR
No#283 Che Xin Rd, Che Dun Zhen, Song Jaing County Shanghai, China C/O: 11F No.201, Nanking East Rd., Sec 3, Taipei, Taiwan, R.O.C Tel:886-2-2713-6677 Fax:886-2-2546-2480
510(k) Summary
Prepared: March 28, 2007
| Applicant | Shanghai China Star Corp
No. 283, Che Xing Road, Che Dun Zhen,
Song Jiang
County: Shanghai, China |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Shanghai China Star Corp
No. 283, Che Xing Road, Che Dun Zhen,
Song Jiang
County: Shanghai, China |
| Submitter | Romil Rambhia
Official Correspondent for
Shanghai China Star Corp |
| Address | mdi Consultants, Inc.
55 Northern Blvd., Suite 200
Great Neck, New York 11021
Tel: 516-482-9001
Fax: 516-482-0186
romil@mdiconsultants.com |
| Trade/proprietary Name | Shanghai China Star Corp
Powder free Blue Nitrile Patient
Examination Glove tested with
chemotherapy drugs. |
| Common Names | POWDER-FREE Patient Examination
Glove |
| Classification name | Patient Examination Glove |
| Classification number | 21 CFR 880.6250 |
Device Description:
Shanghai China Star Corp Powder free blue Nitrile Examination Glove is a class I device having product code 80LZA. It is a disposable device powdered with absorbable dusting powder that meets all requirements of ASTM D 631900a-05 and is tested with chemotherapy drugs.
Intended Use:
A powder free patient examination glove (Tested for Use with Chemotherapy Drugs) is a disposable device intended for medical purposes that is worn on the examiners hand or to prevent finger examiner. These gloves are not intended to be used as a chemical barrier
1
Substantial Equivalence Discussion:
| Characteristic
and parameters | Shanghai China Star
Corp
(New Device) | MEDLINE
INDUSTRIES, INC
(K) 040841 | ALLEGIANCE
HEALTHCARE
CORP.
(K) 022765 |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | LZA | LZA | LZA |
| Intended Use | A powder free patient
examination glove
(Tested for Use with
Chemotherapy Drugs)
is a disposable device
intended for medical
purposes that is worn
on the examiners hand
or finger to prevent
contamination between
patient and examiner.
These gloves are not
intended to be used as a
chemical barrier | Medline Powder-Free
Blue Nitrile
Examination Gloves
(Tested for Use with
Chemotherapy
Drugs) 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 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. In addition,
these gloves are worn
to protect the wearer
against exposure to
chemotherapy drugs.
The gloves with tested
for use with
chemotherapy drugs
labeling claims. |
| Width (size
medium) | 92mm | 92mm | N/A |
| Overall length | 240mm | 240mm | N/A |
| Palm thickness | 0.17mm | 0.17mm | N/A |
| Finger thickness | 0.18mm | 0.18mm | N/A |
| Tensile strength
pre aging min | 21mpa | 21mpa | N/A |
| Tensile strength
after aging min | 16mpa | 16mpa | N/A |
| Ultimate
elongation pre
aging min | 500 | 500 | N/A |
| Ultimate
elongation after
aging min | 500 | 500 | N/A |
| Meets
Biocompatibility
standards | Yes | Yes | Yes |
| Duration of bio-
compatibility | Limited | Limited | Limited |
| Skin irritation test | Passes | Passes | Passes |
| Dermal
sensitization | Passes | Passes | Passes |
| Residual powder
test | Passes | Passes | Passes |
A powder free patient examination glove (Tested for Use with Chemotherapy Drugs) is substantially equivalent to the predicate devices.
2
N/A is we don't know the specifications.
Summary of Testing:
| Test | Results |
|---|---|
| 1. Dermal Sensitization Test | Passes |
| 2. Primary Skin irritation | Passes |
| 3. Permeation testing per ASTM D 6978-05 | Passes |
| 4. Iodine Test | Passes |
| 5. Tensile strength | Gloves meets the requirements of |
| ASTM D63 19-00a. | |
| 6. Barrier strength | Gloves meets the requirements of |
| ASTM D63 19-00a. |
The standards used by Shanghai Chinstar Corp to determine substantial equivalence are based on ASTM D 631900a-2005. All testing meets requirements for physical specifications and dimensions conducted on gloves, Inspection level S-2, AQL 4.0, pinholes at AQL 2.5
There are no special labeling claims and we do not claim our gloves to be hypoallergenic.
Conclusion:
Powder free Blue Nitrile Patient Examination Glove tested with chemotherapy drugs performance was equivalent to any other conventional method evaluated. Our evaluation concluded that our device raises no new issues of Safety and effectiveness.
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a circular design with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem depicting a stylized eagle with three overlapping profiles, symbolizing health, services, and people. The eagle is a common symbol of the United States, representing freedom and strength.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Shanghai China Star Corporation C/O Mr. Romil Rambhia Official Correspondent mdi Consultants, Incorporated 55 Northern Boulevard, Suite 200 Great Neck, New York 11001
AUG 3 0 2007
Re: K071072
Trade/Device Name: Shanghai China Star Corp Powder Free Blue Nitrile Patient Examination Glove Tested with Chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: August 21, 2007 Received: August 22, 2007
Dear Mr. Rambhia:
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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
4
Page 2 -Mr. Rambhia
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits vour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): Not Assigned as of now
1/07/072
Applicant: Shanghai China Star Corp
Device Name: Shanghai China Star Corp Powder free Blue Nitrile Patient Examination Glove tested with chemotherapy drugs.
Indications for Use:
A powder free patient examination glove (Tested for Use with Chemotherapy Drugs) is a disposable device intended for medical purposes that is worn on the examiners hand or finger to prevent contamination between patient and examiner. These gloves are not intended to be used as a chemical barrier.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Shula A Murphy, 6
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K021072