(142 days)
Not Found
No
The device is a disposable medical glove, and the description and performance studies focus on its physical properties and resistance to chemotherapy drugs, with no mention of AI or ML.
No
The device, a disposable medical glove, is intended to prevent contamination and protect personnel, not to treat or diagnose a disease or condition in a patient.
No
Explanation: The device is described as a medical glove intended to prevent contamination, not to diagnose medical conditions. Its performance studies relate to chemotherapy drug permeation, not diagnostic accuracy.
No
The device is a physical medical glove, not a software application. The description clearly states it is a "disposable medical glove" and "Non-sterile, Powder-free Blue Nitrile Examination Gloves".
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to prevent contamination between healthcare personnel and patients by providing a barrier on the hand. This is a physical barrier function, not a diagnostic test performed on a sample taken from the human body.
- Device Description: The description is for a disposable medical glove.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing information for diagnosis, monitoring, or screening.
- Performance Studies: The performance studies focus on the glove's barrier properties against chemotherapy drugs, which is relevant to its protective function, not a diagnostic function.
IVD devices are specifically designed to perform tests on samples from the human body to provide information for medical purposes. This glove does not fit that definition.
N/A
Intended Use / Indications for Use
The Non-sterile 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.
Chemotherapy Drug Permeation (Breakthrough Detection Time) in Minutes
The following chemical have been tested with these gloves.
| Test Chemotherapy Drug | Average Breakthrough Detection Time (Minutes) |
|---|---|
| *Carmustine (BCNU) | 0.49 minutes |
| Cisplatin | >240 minutes |
| Cyclophosphamide (Cytoxan) | >240 minutes |
| Doxorubicin Hydrochloride | >240 minutes |
| Etoposide (Toposar) | >240 minutes |
| Flurouracil | >240 minutes |
| Paclitaxel (Taxol) | >240 minutes |
| *Thiotepa | 2.61 minutes |
| Vincristine Sulfate | >240 minutes |
| Dacarbazine (DTIC) | >240 minutes |
*Please note that Carmustine (BCNU) and Thiotepa have extremely low permeation times of 0.49 and 2.61 minute only.
Prescription Use
Product codes (comma separated list FDA assigned to the subject device)
LZA, LZC
Device Description
Non-sterile , Powder-free Blue Nitrile Examination Gloves , Tested for use 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
healthcare and similar personnel
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)
Chemotherapy Drug Permeation (Breakthrough Detection Time) in Minutes
The following chemical have been tested with these gloves.
| Test Chemotherapy Drug | Average Breakthrough Detection Time (Minutes) |
|---|---|
| *Carmustine (BCNU) | 0.49 minutes |
| Cisplatin | >240 minutes |
| Cyclophosphamide (Cytoxan) | >240 minutes |
| Doxorubicin Hydrochloride | >240 minutes |
| Etoposide (Toposar) | >240 minutes |
| Flurouracil | >240 minutes |
| Paclitaxel (Taxol) | >240 minutes |
| *Thiotepa | 2.61 minutes |
| Vincristine Sulfate | >240 minutes |
| Dacarbazine (DTIC) | >240 minutes |
| Methotrexate | >240 minutes |
*Please note that Carmustine (BCNU) and Thiotepa have extremely low Prease Bott that of 0.49 and 2.61 minute only.
The device meets ASTM D6319-00a-05 for Dimensions, Physical Properties, and Freedom From Pinholes.
The device meets ASTM D6124-06 for Powder-free.
Biocompatibility Test: Passes Primary Skin Irritation in Rabbits, Passes Guinea Pig Maximization.
Chemotherapy Drugs Tests: Meets ASTM D6978-05 for Cisplatin > 240 mins, Cyclophosphamide > 240 mins, Doxorubicin Hydrochloride > 240 mins, Etoposide > 240 mins, Flurouracil > 240 mins, Paclitaxel > 240 mins, Vencristine Sulfate > 240 mins, Dacarbazine > 240 mins, Methotrexate > 240 mins.
The gloves are not approved for use when using Carmustine (BCNU) and Thiotepa due to extremely low permeation times (0.49 and 2.61 minutes respectively).
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
APPENDIX M
( k) SUMMARY 210
( As Required by 21 section 807.92 (c) )
- Submitted For : SGMP Company Limited 181 Moo 6, Tambol Kampaengphet , Rattaphum , Songkhla 90180 Thailand, 2. Submitted By : Tucker & Associates Official Correspondent for SGMP Company Limited Janna P. Tucker , President - CEO 198 , Avenue de la D'emerald , Sparks, NV 89434-9550 Phone No : 775-342-2612 Fax No : 775-342-2613 Email : Tuckerjan@aol.com r
3. Device Trade or Proprietary Name :
Non-sterile , Powder-free Blue Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs.
-
- Device Common Name : Examination Gloves
5. Device Classification Name :
Patient Examination Gloves ( per 21CFR 880.6250)
6. Device Description :
Non-sterile , Powder-free Blue Nitrile Examination Gloves , Tested for use with Chemotherapy Drugs.
7. Intended Use of Device :
A disposable medical glove to be worn on the hand of the healthcare and similar personnel to prevent contamination between healthcare personnel and patient.
ATCH 2
APPENDIX M revised 10-12-10, James Packer
Now shows equivalence to K082957.
NOV 1 9 2010
1
K101822
The Non-sterile Powder Free Blue Nitrile Examination Gloves Tested for uses with The Non-sterile Powder Free Blue device intended for medical purposes that is world on the Chemotherapy Drugs , is a disposable device intended to models paper
Chemotherapy Drug Permeation (Breakthrough Detection Time) in Minutes
In Minutes of the March and with these gloves Chemotherapy Drug i cinicallon (Broadiness). The following chemical
| Test Chemotherapy Drug | Average Breakthrough Detection Time (Minutes) |
|---|---|
| *Carmustine (BCNU) | 0.49 minutes |
| Cisplatin | >240 minutes |
| Cyclophosphamide (Cytoxan) | >240 minutes |
| Doxorubicin Hydrochloride | >240 minutes |
| Etoposide (Toposar) | >240 minutes |
| Flurouracil | >240 minutes |
| Paclitaxel (Taxol) | >240 minutes |
| *Thiotepa | 2.61 minutes |
| Vincristine Sulfate | >240 minutes |
| Dacarbazine (DTIC) | >240 minutes |
| Methotrexate | >240 minutes |
*Please note that Carmustine (BCNU) and Thiotepa have extremely low Prease Bott that of 0.49 and 2.61 minute only.
ﺮ
2
KID/822
(1) = 1.
・
· 8. Substantial Equivalence Discussion :
.
... ..
ﻨﻲ
| Characteristic and
Parameter | SGMP Company Limited
Non-sterile , Powder-free Blue Nitrile
Examination Gloves.
Tested for use with Chemotherapy
Drugs | Siam Sempermed Corp.Ltd.
Non-sterile , Powder-free Nitrile
Examination Glove , Blue with
Polymer Coating, Tested for use
with Chemotherapy Drugs
510 K # K082957 | Substantial
Equivalence
(SE) |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|
| Devise Class | 1 | 1 | SE |
| Product Code | LZA | LZA | SE |
| Glove Color | Blue | Blue | SE |
| Dimensions | Meets ASTM D6319-00a-05 | Meets ASTM D6319-00a-05 | SE |
| Physical
Properties | Meets ASTM D6319-00a-05 | Meets ASTM D6319-00a-05 | SE |
| Freedom From
Pinholes | Meets ASTM D6319-00a-05 | Meets ASTM D6319-00a-05 | SE |
| Powder-free | Meets ASTM D6124-06 | Meets ASTM D6124-06 | SE |
| Biocompatibility
Test | Passes Primary Skin Irritation
in Rabbits | Passes Primary Skin Irritation
in Rabbits | SE |
| | Passes Guinea Pig
Maximization | Passes Guinea Pig
Sensitization | SE |
| Chemotherapy
Drugs Tests | Meets ASTM D6978-05
Cisplatin > 240 mins | Meets ASTM D6978-05
Cisplatin > 240 mins | SE |
| | Cyclophosphamide > 240 mins
Doxorubicin Hydrochloride | Cyclophosphamide > 240 mins
Doxorubicin Hydrochloride | |
| | > 240 mins
Etoposide > 240 mins | > 240 mins
Etoposide > 240 mins | |
| | Flurouracil > 240 mins
Paclitaxel > 240 mins | Flurouracil > 240 mins
Paclitaxel > 240 mins | |
| | Vencristine Sulfate > 240 mins
Dacarbazine > 240 mins | Vencristine Sulfate > 240 mins
Dacarbazine > 240 mins | |
| | Methotrexate > 240 mins | Methotrexate > 240 mins | |
.
3
:
.
4
CONCLUSION:
The data presented indicates the Powder-Free, Blue Nitrile Examination Gloves, Tested I the una presence managers wabeling Claim, (Non-Sterile), K.101822 is equivalent 101 OSC With Channellapy Doles-free Nitrile Examination Gloves, Blue with Polymer Coating, Tested for use with Chemotherapy Drugs.
It should be noted that testing for use with two chemotherapy drugs had extremely It should be loced use total use as follows: CARMUSTINE (BCNU) @ 0.49 minutes, and iow permeation unles. Therefore, these gloves are not approved for use when using those chemo drugs.
These gloves do meet the following recognized standards unless otherwise noted:
ASTM D6319-00a00A(2005), Standard Specification for Nitrile Gloves
ISO 2859-1, Standard for Water Leak Test and/or ASTM D5151-06, Test Method for Detection of Holes in Medical Gloves
ASTM D6124-06, Standard Test Method for Residual Powder on Medical Gloves.
Biocompatibility Testing on White Rabbits and Guinea Pigs,
Labeling meets FDA requirement
Substantially equivalent to Siam Sempermed Corp. Ltd. K082957
ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of two main elements: a circular seal on the left and a stylized symbol on the right. The seal contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference of a circle. The symbol on the right features a stylized human figure with three arms, representing the department's mission to protect the health of all Americans.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
SGMP Company, Limited C/O Ms. Janna P. Tucker Tucker & Associates 198 Avenue De La D'Emerald Sparks. Nevada 89434
NOV 1 9 2010
Re: K101822
Trade/Device Name: Non-Sterile, Powder Free Blue Nitrile Examination Gloves Tested for use with Chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA/LZC Dated: October 22, 2010 Received: October 21, 2010
Dear Ms. Tucker:
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. 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.
6
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 531-542 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
for
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
INDICATION FOR USE STATEMENT
-00.
| Applicant : SGMP Company Limited | |
|---|---|
| 510K NUMBER: K10 1822 | |
| Device Name : Non-Sterile, Powder Free Blue Nitrile Examination Gloves , Tested for use with | |
| Chemotherapy Drugs. | |
| Indication For Use : | |
| The Non-sterile 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. | |
| Chemotherapy Drug Permeation (Breakthrough Detection Time) in Minutes | |
| The following chemical have been tested with these gloves. | |
| Test Chemotherapy Drug | Average Breakthrough |
| Detection Time (Minutes) | |
| *Carmustine (BCNU) | 0.49 minutes |
| Cisplatin | >240 minutes |
| Cyclophosphamide (Cytoxan) | >240 minutes |
| Doxorubicin Hydrochloride | >240 minutes |
| Etoposide (Toposar) | >240 minutes |
| Flurouracil | >240 minutes |
| Paclitaxel (Taxol) | >240 minutes |
| *Thiotepa | 2.61 minutes |
| Vincristine Sulfate | >240 minutes |
| Dacarbazine (DTIC) | >240 minutes |
*Please note that Carmustine (BCNU) and Thiotepa have extremely low permeation times of 0.49 and 2.61 minute only.
Prescription Use ........................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................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