(141 days)
(K) 071072, (K) 040841
Not Found
No
The device is a disposable examination glove, and the summary focuses on material properties and performance testing related to barrier function and skin irritation. There is 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 disease or condition.
No
The device is described as a "patient examination glove" intended to prevent contamination between patient and examiner, not to diagnose a condition.
No
The device description clearly states it is a physical glove made of nitrile, which is a hardware component. The summary focuses on physical properties and testing of the glove material.
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 from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description reinforces that it's a "disposable device" that meets standards for physical properties and barrier strength.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing diagnostic information
- Using reagents or assays
The testing described focuses on the physical properties of the glove (dermal sensitization, skin irritation, permeation, tensile strength, barrier strength), which are relevant to its function as a protective barrier, not as a diagnostic tool.
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.
Product codes (comma separated list FDA assigned to the subject device)
LZA
Device Description
Sunmax Enterprise Shanghai Co Powder free blue Nitrile Examination Glove is a class II device having product code 80LZA. It is a disposable device 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
hand or finger
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)
The device underwent the following tests:
a. Dermal Sensitization Test - Passes
b. Primary Skin irritation - Passes
c. Permeation testing per ASTM D 6978-05 - Passes
d. Iodine Test - Passes
e. Tensile strength - Gloves meets the requirements of ASTM D63 19-00a.
f. Barrier strength - Gloves meets the requirements of ASTM D63 19-00a.
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) 071072, (K) 040841
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
EXHIBIT #3
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
1. Applicant:
Sunmax Enterprise Shanghai Co., Ltd No.2 New Industrial Area, Zhu Hang Zhen Jin Shan Xian, Shanghai, China
JUL - 1 2009
- Manufacturer: Sunmax Enterprise Shanghai Co., Ltd No.2 New Industrial Area, Zhu Hang Zhen Jin Shan Xian, Shanghai, China
3. Submitter:
Mr. Jigar Shah Official Correspondent for Sunmax Enterprise Shanghai Co., Ltd
4. Address:
mdi Consultants, Inc. 55 Northern Blvd., Suite 200 Great Neck, New York 11021 Tel: 516-482-9001 Fax: 516-482-0186 jigar@mdiconsultants.com
5. Trade/proprietary Name:
Sunmax Enterprise Shanghai Co Powder free Blue Nitrile Patient Examination Glove tested with chemotherapy drugs.
-
- Common Names: POWDER-FREE Patient Examination Glove
7. Classification name: Patient Examination Glove
-
- Classification number: 21 CFR 880.6250
1
9. Device Description:
Sunmax Enterprise Shanghai Co Powder free blue Nitrile Examination Glove is a class II device having product code 80LZA. It is a disposable device that meets all requirements of ASTM D 631900a-05 and is tested with chemotherapy drugs.
10. 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.
11. Substantial Equivalence Discussion:
A powder free patient examination glove (Tested for Use with Chemotherapy Drugs) is substantially equivalent to the predicate devices.
| Characteristic
and parameters | Sunmax
Enterprise
Shanghai Co.,
LTD (New
Device) | Shanghai China
Star Corp
(K) 071072 | MEDLINE
INDUSTRIES,
INC
(K) 040841 | Substantial
Equivalence
(SE) |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|
| 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 | 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. | SE |
| Width (size
medium) | 89mm | 92mm | 92mm | Minor
difference |
2
2
| Overall length | 240mm | 240mm | 240mm | SE |
|---|---|---|---|---|
| Palm thickness | 0.12mm | 0.17mm | 0.17mm | |
| Finger thickness | 0.12mm | 0.18mm | 0.18mm | |
| Tensile strength | ||||
| pre aging min | 18mpa | 21mpa | 21mpa | |
| Tensile strength | ||||
| after aging min | 18mpa | 16mpa | 16mpa | |
| Ultimate | ||||
| elongation pre | ||||
| aging min | 600 | 500 | 500 | Minor |
| difference | ||||
| Ultimate | ||||
| elongation after | ||||
| aging min | 570 | 500 | 500 | |
| Meets | ||||
| Biocompatibility | Yes | Yes | Yes | |
| Duration of bio- | ||||
| compatibility | Limited | Limited | Limited | |
| Skin irritation test | Passes | Passes | Passes | SE |
| Dermal | ||||
| sensitization | Passes | Passes | Passes | |
| Residual powder | ||||
| test | Passes | Passes | Passes |
- Summary of Testing:
| Test | Results | |
|---|---|---|
| a. | Dermal Sensitization Test | Passes |
| b. | Primary Skin irritation | Passes |
| c. | Permeation testing per ASTM D 6978-05 | Passes |
| d. | Iodine Test | Passes |
| e. | Tensile strength | Gloves meets the requirements of |
| ASTM D63 19-00a. | ||
| f. | Barrier strength | Gloves meets the requirements of |
| ASTM D63 19-00a. |
The standards used by Sunmax Enterprise Shanghai Co 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.
3
13. 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.
.
4
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.
Public Health Service
JUL - 1 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Sunmax Enterprise Shanghai Company, Limited C/O Mr. Jigar Shah mdi Consultants, Incorporated 55 Northern Boulevard, Suite 200 Great Neck, New York 11021
Re: K090336
Trade/Device Name: Powder-Free, Blue, Nitrile Examination Gloves Tested with
Chemotherapy Drugs
Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA, LZC Dated: June 25, 2009 Received: June 30, 2009
Dear Mr. Shah:
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 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.
5
Page 2 - Mr. Shah
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections $31-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/ CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Anthony D.m
Susan Runner, D.D.S., M.A.
Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
EXHIBIT #1
Indications for Use
510(k) Number (if known): K090336
Applicant: Sunmax Enterprise Shanghai Co Ltd
Device Name: 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.
Chemotherapy drugs with their breakthrough times:
| Dacarbazine | 240 minutes |
|---|---|
| Cyclophosphamide(Cytoxan) | 240 minutes |
| Doxorubicin Hydrochloride | 240 minutes |
| Fluorouracil | 240 minutes |
| Cisplatin | 240 minutes |
| Etoposide (Toposar) | 240 minutes |
| Paclitaxel (Taxol) | 240 minutes |
| Thio-Tepa | 23.3 minutes |
| Carmustine | 18.7 minutes |
Prescription Use AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use X (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)
Shule A Murphy, MD
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K090336