Powder free, Non-sterile, Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl

K233520 · Anhui Powerguard Technology Co., Ltd. · LZA · Jan 12, 2024 · General Hospital

Device Facts

• Record ID: K233520
• Device Name: Powder free, Non-sterile, Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl
• Applicant: Anhui Powerguard Technology Co., Ltd.
• Product Code: LZA · General Hospital
• Decision Date: Jan 12, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

The Powder free, Non-sterile, Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl, is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Device Story

Disposable, non-sterile, blue nitrile examination gloves; ambidextrous; available in sizes XS-XL. Worn by healthcare examiners to prevent cross-contamination between patient and examiner. Tested for permeation resistance against specific chemotherapy drugs and Fentanyl per ASTM D6978. Used in clinical settings. Output is physical barrier protection. Benefits include protection against patient-to-examiner contamination and specific chemical exposure during handling of chemotherapy agents and Fentanyl.

Clinical Evidence

No clinical data. Bench testing only. Performance demonstrated via ASTM D6319 (physical dimensions, tensile strength, elongation), ASTM D6124 (residual powder), ASTM D5151 (freedom from holes), and ASTM D6978 (chemotherapy drug permeation). Biocompatibility testing performed per ISO 10993-1, including cytotoxicity, irritation, sensitization, and acute systemic toxicity.

Technological Characteristics

Material: Nitrile. Form factor: Ambidextrous, powder-free, blue, non-sterile. Dimensions: Length 220-230mm, thickness ≥0.05mm. Standards: ASTM D6319 (physical), ASTM D6978 (chemotherapy permeation), ASTM D6124 (powder), ASTM D5151 (holes). Biocompatibility: ISO 10993-5, 10993-10, 10993-11, 10993-23.

Indications for Use

Indicated for use as a disposable, non-sterile, patient examination glove worn on the examiner's hand to prevent cross-contamination between patient and examiner. Tested for use with specific chemotherapy drugs and Fentanyl. Contraindicated for use with Carmustine and Thiotepa.

Regulatory Classification

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.

Predicate Devices

• Non-Sterile, Single use, Powder-free examination glove, Blue, tested for use with Chemotherapy drugs and Fentanyl (K223903)

Submission Summary (Full Text)

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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: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

January 12, 2024

Anhui Powerguard Technology Co., Ltd. % Ivy Wang Technical Manager Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Central Avenue Shanghai, Shanghai 200122 China

Re: K233520

Trade/Device Name: Powder free, Non-sterile, Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I. reserved Product Code: LZA, LZC, OPJ, QDO Dated: November 1, 2023 Received: November 1, 2023

Dear Ivy Wang:

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 (the 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 available 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# llan v

For Bifeng Qian, M.D., Ph.D. Assistant Director

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DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

#### 510(k) Number (if known) K233520

#### Device Name

Powder free, Non-sterile, Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl

Indications for Use (Describe)

The Powder free, Non-sterile, Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentany1, is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. The tested chemotherapy drugs are: Chemotherapy drug Concentration Minimum Breakthrough Detection Time Carmustine ( 3.3mg/mL 3,300 ppm) 11.1 min Cisplatin ( 1.0 mg/mL 1,000 ppm) >240 min Cyclophosphamide (20 mg/mL 20,000 ppm) >240 min Cytarabine (Cytosine) (100 mg/mL 100,000 ppm) >240 min Dacarbazine (10 mg/mL 10,000 ppm) >240 min Doxorubicin (Adriamycin) (2.0 mg/mL 2,000 ppm) >240 min Etoposide (Toposar) (20.0 mg/mL 20,000 ppm) >240 min Fluorouracil (5 Flu) (50.0 mg/mL 50,000 ppm) >240 min Ifosfamide (50.0 mg/mL 50,000 ppm) >240 min Methotrexate (25.0 mg/mL 25,000 ppm) >240 min Mitomycin C (0.5 mg/mL 500 ppm) >240 min Mitoxantrone HCL (2.0 mg/mL 2,000 ppm >240 min Paclitaxel (6.0 mg/mL 6,000 ppm) >240 min Thiotepa (10.0 mg/mL 10.000 ppm) 34.8 min Vincristine Sulfate (1.0 mg/mL 1,000 ppm >240 min Fentanyl Citrate Injection (100 mcg/2mL) >240 min Note: Carmustine and Thiotepa have extremely low permeation times of 11.1 and 34.8 minutes respectively. Warning: Do Not Use with Carmustine. Thiotepa

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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# 510(K) Summary

## K233520

(As required by 21 CFR 807.92)

Date prepared: 2024-01-12

#### A. Applicant:

Name: Anhui Powerguard Technology Co., Ltd. Address: Lingbi North Development Zone, Suzhou City, Anhui Province, China Contact: Mr. Nick Dai Title: Vice General Manager Tel: [phone] Email: [e-mail]

Submission Correspondent: Primary contact: Ms. Ivy Wang Shanghai SUNGO Management Consulting Co., Ltd. Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: [phone] Email: [e-mail] Secondary contact: Mr. Raymond Luo Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: [phone] Email: [e-mail]

### B. Device:

Trade Name: Powder free, Non-sterile, Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl Common Name: Nitrile Patient Examination Gloves (Powder Free) Size(s): XS, S, M, L, XL

### Regulatory Information

Classification Name: Polymer Patient Examination Glove Classification: Class I Product code: LZA, LZC, OPJ, QDO Regulation Number: 21 CFR 880.6250 Review Panel: General Hospital

### C. Predicate device:

K223903 Non-Sterile, Single use, Powder-free examination glove, Blue, tested for use with Chemotherapy drugs and Fentanyl SEMPERIT INVESTMENTS ASIA PTE. LTD.

### D. Indications for use of the device:

The Powder free, Non-sterile, Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs and

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Fentanyl, is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

The tested chemotherapy drugs are:

| Chemotherapy drug | Concentration | Minimum Breakthrough Detection Time |
|----------------------------|-------------------------|-------------------------------------|
| Carmustine | (3.3mg/mL 3,300 ppm) | 11.1 min |
| Cisplatin | (1.0 mg/mL 1,000 ppm) | >240 min |
| Cyclophosphamide | (20 mg/mL 20,000 ppm) | >240 min |
| Cytarabine (Cytosine) | (100 mg/mL 100,000 ppm) | >240 min |
| Dacarbazine | (10 mg/mL 10,000 ppm) | >240 min |
| Doxorubicin (Adriamycin) | (2.0 mg/mL 2,000 ppm) | >240 min |
| Etoposide (Toposar) | (20.0 mg/mL 20,000 ppm) | >240 min |
| Fluorouracil (5 Flu) | (50.0 mg/mL 50,000 ppm) | >240 min |
| Ifosfamide | (50.0 mg/mL 50,000 ppm) | >240 min |
| Methotrexate | (25.0 mg/mL 25,000 ppm) | >240 min |
| Mitomycin C | (0.5 mg/mL 500 ppm) | >240 min |
| Mitoxantrone HCL | (2.0 mg/mL 2,000 ppm) | >240 min |
| Paclitaxel | (6.0 mg/mL 6,000 ppm) | >240 min |
| Thiotepa | (10.0 mg/mL 10,000 ppm) | 34.8 min |
| Vincristine Sulfate | (1.0 mg/mL 1,000 ppm) | >240 min |
| Fentanyl Citrate Injection | (100 mcg/2mL) | >240 min |

Note: Carmustine and Thiotepa have extremely low permeation times of 11.1 and 34.8 minutes respectively. Warning: Do Not Use with Carmustine, Thiotepa

### E. Device Description:

The Powder free, Non-sterile, Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl are non-sterile, single use only, disposable examination gloves intended for medical purposes to be worn by examiners to prevent contamination between the patient and the examiner. The gloves are blue color, powder free, nitrile ambidextrous gloves are offered in five sizes, extra small, small, medium, large, and extra-large, packed in a paper box.

The gloves are designed and manufactured in accordance with the ASTM D6319 standard and are tested for use with chemotherapy drugs and Fentanyl per ASTM D6978 standard.

### F. Summary of Technological Characteristics

Table 1 General Comparison of Proposed and Predicate Devices

| Device | Proposed Device | Predicate Device | Result |
|--------|-----------------|------------------|--------|
|--------|-----------------|------------------|--------|

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| 510K # | | K223903 | - |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Product Name | Powder free, Non-sterile, Blue Nitrile<br>Examination Gloves, Tested for Use with<br>Chemotherapy Drugs and Fentanyl | Non-Sterile, Single use, Powder-free<br>examination glove, Blue, tested for<br>use with Chemotherapy drugs and<br>Fentanyl | - |
| Product Code | LZA (primary), LZC, OPJ, QDO | LZA (primary), LZC, OPJ, QDO | Same |
| Classification | Class I | Class I | Same |
| Regulation<br>Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Indications for<br>use | The Powder free, Non-sterile, Blue Nitrile<br>Examination Glove, Tested for Use with<br>Chemotherapy Drugs and Fentanyl, is a<br>disposable device intended for medical<br>purposes that is worn on the examiner's hand<br>to prevent contamination between patient<br>and examiner.<br>The tested chemotherapy drugs are:<br>Chemotherapy drug Concentration Minimum<br>Breakthrough Detection Time<br>Carmustine (3.3mg/mL 3,300 ppm) 11.1<br>Cisplatin (1.0 mg/mL 1,000 ppm) >240 min<br>Cyclophosphamide (20 mg/mL 20,000 ppm)<br>> 240 min<br>Cytarabine (Cytosine) (100 mg/mL 100,000<br>ppm) >240 min<br>Dacarbazine (10 mg/mL 10,000 ppm) ><br>240 min<br>Doxorubicin (Adriamycin) (2.0 mg/mL 2,000<br>ppm) >240 min<br>Etoposide (Toposar) (20.0 mg/mL 20,000<br>ppm) >240 min<br>Fluorouracil (5 Flu) (50.0 mg/mL 50,000<br>ppm) >240 min<br>Ifosfamide (50.0 mg/mL 50,000 ppm) ><br>240 min<br>Methotrexate (25.0 mg/mL 25,000 ppm)<br>> 240 min<br>Mitomycin C (0.5 mg/mL 500 ppm) >240<br>min<br>Mitoxantrone HCL (2.0 mg/mL 2,000 ppm ><br>240 min<br>Paclitaxel (6.0 mg/mL 6,000 ppm) >240<br>min | This device is an ambidextrous patient<br>examination glove that is a non-sterile,<br>single use, disposable device intended<br>for medical purposes, worn on the<br>examiner's hand or finger to prevent<br>contamination between patient and<br>examiner.<br>The tested chemotherapy drugs are:<br>Carmustine (BCNU) (3.3 mg/ml).<br>Permeation time: Carmustine (BCNU)<br>has extremely low permeation times of<br>14.7 minutes.<br>Cisplatin (1.0 mg/ml). Permeation time:<br>no breakthrough up to 240 minutes<br>Cyclophosphamide (Cytoxan) (20.0 mg/<br>ml). Permeation time: no breakthrough<br>up to 240 minutes<br>Cytarabine (100 mg/ml). Permeation<br>time: no breakthrough<br>up to 240 minutes Dacarbazine (DTIC)<br>(10.0 mg/ml). Permeation time: no<br>breakthrough up to 240 minutes<br>Doxorubicin Hydrochloride (2.0 mg/ml).<br>Permeation time: no breakthrough up to<br>240 minutes<br>Etoposide (20.0 mg/ml). Permeation<br>time: no breakthrough up to 240<br>minutes<br>Fluorouracil (50.0 mg/ml).<br>Permeation time: no breakthrough up to<br>240 minutes<br>Ifosfamide (50.0 mg/ml). Permeation<br>time: no breakthrough up to 240<br>minutes | Similar |
| | Thiotepa (10.0 mg/mL 10,000 ppm) 34.8 | Methotrexate (25.0 | |
| | Vincristine Sulfate (1.0 mg/mL 1,000 ppm | mg/ml). Permeation time: no | |
| | >240 min | breakthrough up to 240 minutes | |
| | Fentanyl Citrate Injection (100 mcg/2mL) > | Mitomycin C (0.5 mg/ml). Permeation | |
| | 240 min | time: no breakthrough up to 240 | |
| | Note: Carmustine and Thiotepa have | minutes | |
| | extremely low permeation times of 11.1 and | Mitoxantrone (2.0 mg/ml). | |
| | 34.8 minutes respectively. | Permeation time: no breakthrough up to | |
| | Warning: Do Not Use with Carmustine, | 240 minutes Paclitaxel (Taxol) (6.0 | |
| | Thiotepa | mg/ml). Permeation time: no | |
| | | breakthrough up to 240 minutes | |
| | | Thiotepa (10.0 mg/ml). Permeation | |
| | | time: Thiotepa has extremely low | |
| | | permeation times of 13.6 minutes | |
| | | Vincristine Sulfate (1.0 mg/ml). | |
| | | Permeation time: no Breakthrough up | |
| | | to 240 minutes. | |
| | | The tested Opiod is: | |
| | | Fentanyl Citrate Injection | |
| | | (100mcg/2mL). Permeation: no | |
| | | breakthrough up to 240 minutes | |
| | | Please note that the following drugs | |
| | | have extremely low permeation times:…